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General Summary: Completes general activities on the production floor. Benefits and Culture We offer a competitive compensation and benefits package designed to help employees live a healthier life, build rewarding careers and save for the future. Reser's offers choices whenever possible, because we recognize the diverse and ever changing needs of our employees. Benefits include medical, dental, vision, AD&D, life, 401(k) with discretionary match, wellness programs, paid holidays and vacation time to name few! We strive to be your Employer of Choice. As one of our five cornerstones, this means that we go all-out to create an environment where people choose a lasting career because Reser’s care about their personal development & safety, and delivers a rewarding work experience. Visit our website to learn more about our competitive benefit programs - https://www.resers.com/careers/#benefits Principal Duties and Responsibilities 1. Assists with production, preparation, and storage of company products. 2. Places boxed products on a pallet. 3. Maintains housekeeping of the production plant and warehouse. 4. Follows company safety guidelines and Good Manufacturing Practices. Job Specifications 1. Must be able to follow directions. 2. English/Spanish bilingual is a plus. Working Conditions 1. Refrigerated food manufacturing plant. 2. The environment may be wet, or dry, and temperatures may range from 25°F to 110°F. 3. Repetitive lifting, kneeling, and bending with packages in excess of 35 lbs is required. 4. Requires walking and standing for long periods of time. 5. Production demands may require overtime and/or evening or weekend scheduling. Compensation: $17.25 + $1.00 shift differential per hour/non-exempt. Recipe for Success Reser’s is the leading provider of fresh refrigerated deli salads, side dishes, and prepared foods for the supermarket, club store, and food service industries. Family owned and operated, Reser’s has been a proud sponsor of good times at racetracks, picnics, BBQs, music festivals, and affordable family meals since 1950. Reser’s family of brands include Reser’s American Classics, Main St Bistro, Stonemill Kitchens, and more. With more than 4,500 employees, Reser’s operates 14 facilities in the US, Mexico, and Canada and actively supports the communities it serves. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Job Title: Operator l Shift 2: Mon-Thurs, 3pm-1:30am Pay Range: $18-$23/hour + $1/hour shift differential ARCH-Escondido is looking for a motivated Machine Operator. We are a company with unmatched manufacturing technology and a team of people who are committed to keeping their promises. ARCH Medical Solutions is your trusted resource for precision machining, contract manufacturing, and related supply chain integration. At high-tech facilities across the country, we bring deep experience to the development of orthopedic, spine, and dental implants and instruments, navigated and robotic-assisted surgical devices, and precision components for surgical robotic systems, biomedical machines and life sciences equipment. Summary Responsibilities will include, but not limited to supporting the operation of CNC 3-axis milling machines, primarily HAAS equipment. Essential Duties and Responsibilities include the following. Other duties may be assigned. Operates automatic or other machines to produce parts according to blueprints, traveler package, specifications and/ or special instructions. Ensures material is maintained in bar loader. Checks parts for conformance to specification using gages, SPC and shop floor system. Follows 3-cup system for inspection. Starts and observes machine operation to detect malfunctions or out-of-tolerance machining and adjusts machine controls or control media as required. Cleans, counts, and packages product. Communicate problems or concerns regarding machines, parts, equipment. Clearly writes shift notes, fills out inspection forms, and production logs. Completes preventative maintenance and cleaning tasks for machines; mopping oil, emptying chips, etc. Demonstrates accuracy and thoroughness; monitors own work to ensure quality. Ensures safety protocols are followed including wearing proper PPE, reports potentially unsafe conditions; uses equipment and materials properly. Accurately logs data into ERP system. Uses basic math for conversions, addition, subtraction, multiplication, and division in all units of measure, using whole numbers, common fractions, and decimals. Other duties assigned. Competencies To perform the job successfully, an individual should demonstrate the following competencies: Quality - Demonstrates accuracy and thoroughness; monitors own work to ensure quality. Able to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Education and/or Experience High School Diploma or general education degree (GED) and 1 year in college or technical school or equivalent combination of education and experience General machine shop practice experience preferred but not required Experience with 3-axis HAAS CNC machines preferred Basic computer skills Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is frequently required to stand and walk. The employee is occasionally required to sit; use hands to finger, handle, or feel; reach with hands and arms and stoop, kneel, crouch, or crawl. The employee must lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus. Benefits: Medical, dental, vision Medical and Dependent Care FSA Company sponsored life and AD&D 401k with generous employer match Paid-time off Additional Notes ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Job Title: Operator l, Finishing Shift 1: Mon-Thurs, 4:30am-3pm Pay Range: $18-$20/hour ARCH-Escondido is looking for a motivated Operator for our secondary finishing processes. We are a company with unmatched manufacturing technology and a team of people who are committed to keeping their promises. ARCH Medical Solutions is your trusted resource for precision machining, contract manufacturing, and related supply chain integration. At high-tech facilities across the country, we bring deep experience to the development of orthopedic, spine, and dental implants and instruments, navigated and robotic-assisted surgical devices, and precision components for surgical robotic systems, biomedical machines and life sciences equipment. Summary Responsibilities will include, but not limited to, running, or tending, to one or more functions within the manufacturing process, upon request, such as deburring, polishing, cleaning, assembly, or performing finishing operations. Essential Duties and Responsibilities include the following. Other duties may be assigned. Operates machines or processes as needed to meet customer demand and quality requirements. Cleans, deburrs, polishes, or grinds items of metal, plastic, or rubber. Observes machine operation and performs in-process inspections to ensure customer products conform to established standards. Reads customer or manufacturing prints and specifications; interprets dimensions, tolerances, number or parts to be formed, and tooling instruction on type tooling required. Inspects product using calipers, micrometers, overlays, comparators, or other measuring instruments to verify conformance to prints, specifications, or manufacturing work instructions and standard operating procedures. Records information such as; first article inspection, in-process inspection, number of products tested, meter readings, and dates and times of work piece production. Uses data collection software to record productivity output. Performs basic preventative maintenance on processes and assigned machines as requested. Education and/or Experience High school diploma or general education degree (GED); or One-year related experience and/or training; or equivalent combination of education and experience. Read and interpret blueprints or other job specifications. Ability to make all inspections on machined parts using precision measuring equipment. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is frequently required to stand and walk. The employee is occasionally required to sit; use hands to finger, handle, or feel; reach with hands and arms and stoop, kneel, crouch, or crawl. The employee must lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus. Benefits: Medical, dental, vision Medical and Dependent Care FSA Company sponsored life and AD&D 401k with generous employer match Paid-time off Additional Notes ARCH Global Precision is an Equal Opportunity Employee and wholeheartedly supports diversity in the workplace as a basic premise for business success. All employees of ARCH Global Precision are employed on an at-will basis. This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. A review of this position has excluded the marginal functions of the position that are incidental to the performance of fundamental job duties. All duties and responsibilities are essential job functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbent(s) will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Leading designer and manufacturer of innovative interconnect products and complex cable assemblies has an immediate opening for a Tester with Soldering skills. Duties/Responsibilities: * Checks Customer Specification Sheet (CSS) to determine required assembly, exterior finish on product, and any special options. * Uses various machines and hand tools to accomplish assigned tasks. * Maintains logs, records, and reports concerning production, machine maintenance, and product inconsistencies. * May do one or more of these functions: solder; assembly of components into sets or sub-assemblies; crimping; electrical testing; pull-testing; stripping machines; * Perform functional testing to ensure assembled products meet quality standards * Reports other problems to line supervisor or quality control inspector for assistance. * Reporting of quantity and in process inspection on traveler as required. * Solder components with precision and care following safety procedures. * Safely lift and carry materials and finished products weighing up to 50 lbs. * Maintains clean and safe working environment in line with company policies. * Follow all safety protocols and company policies. * Performs other related duties as assigned. Required Skills/Abilities: * Detail-oriented and consistent. * Previous experience in assembly, soldering and testing. * Ability to use soldering equipment and testing tools effectively. * Works well as a productive member of a team. * Experience in intricate hand assembly on paced assembly line depending on whether entry-level or more senior assembly position. * Knowledge of hand and automated tools; soldering irons and soldering tools. * Use of electrical meters; pc based automated electrical test equipment and high potential low amperage equipment, hand presses. Education and Experience: * High school diploma or equivalent required. Physical Requirements: * Prolonged periods standing and performing repetitive tasks. * Must be able to lift up to 50 pounds at a time. * Must have manual dexterity in order to assemble products or machines as directed. * Must have excellent hand-eye coordination. * Ability to differentiate between colored wires, tabs, and electronic components. * Must wear gloves and eye protection when required. Job Type: Full-time Pay: $21.00 - $23.00 per hour Benefits: * Health insurance Work Location: In person
Lumos Diagnostics develops, manufactures, and distributes innovative diagnostic products — delivering actionable information, in real time, at the point of care. We are seeking *Manufacturing Technician II* to join our Carlsbad team and play a vital role in producing cutting-edge diagnostic devices that improve healthcare worldwide. In this role, you’ll set up and operate production equipment, perform assembly, pouching, and kitting, and support specialized device assembly and calibration. You’ll ensure accuracy, safety, and compliance with FDA and ISO 13485 standards, while collaborating with cross-functional teams and mentoring junior technicians. We’re looking for someone with 1–3 years of manufacturing or assembly experience in a regulated environment, strong knowledge of GMP and ISO 13485, and the ability to use hand tools, perform basic troubleshooting, and maintain precise documentation. An associate’s degree in a technical field is preferred but not required. At Lumos, your work makes a direct impact. We offer competitive hourly pay ($22.12 – $25.00), benefits effective the *first day of the month following hire*, and a supportive, growth-oriented culture. If you’re eager to contribute to innovative diagnostics and grow your career, we encourage you to apply today. Job Type: Full-time Pay: $22.12 - $25.00 per hour Expected hours: 40 per week Benefits: * 401(k) * 401(k) 4% Match * 401(k) matching * Dental insurance * Employee assistance program * Employee discount * Flexible spending account * Health insurance * Health savings account * Life insurance * Paid time off * Parental leave * Tuition reimbursement * Vision insurance Education: * Associate (Preferred) Experience: * GMP: 1 year (Required) * Manufacturing: 1 year (Required) * Assembly: 1 year (Required) * FDA regulations: 1 year (Required) * ISO 13485: 1 year (Required) * Hand tools: 1 year (Required) * Calibration: 1 year (Preferred) * Quality inspection: 1 year (Preferred) Location: * Carlsbad, CA 92010 (Required) Shift availability: * Day Shift (Required) Ability to Commute: * Carlsbad, CA 92010 (Required) Ability to Relocate: * Carlsbad, CA 92010: Relocate before starting work (Required) Work Location: In person
*Join Lumos Diagnostics as a Manufacturing Scientist I!* Play a key role in scaling innovative diagnostic assays that improve patient care. Competitive salary ($90,000–$110,000) + comprehensive benefits starting the first of the month following hire. *About the Role* Lumos Diagnostics is seeking a Manufacturing Scientist I to join our Carlsbad team. In this role, you’ll support the transfer, optimization, and scale-up of diagnostic assays and processes from development into manufacturing. Your expertise will directly contribute to ensuring high-quality, reliable products that improve healthcare outcomes. *Responsibilities* * Support transfer and scale-up of diagnostic assays and manufacturing processes. * Perform process optimization, troubleshooting, and validation activities. * Collaborate with cross-functional teams (R&D, Quality, Manufacturing) to ensure smooth product launches. * Maintain accurate documentation in compliance with FDA, ISO 13485, and GMP requirements. * Provide technical support for manufacturing teams, including training and mentoring. *Requirements* * Bachelor’s degree in Biochemistry, Molecular Biology, Engineering, or related field. * 1–3 years of relevant laboratory, process development, or manufacturing experience (medical device or diagnostics preferred). * Strong knowledge of GMP, ISO 13485, and regulated environments. * Hands-on experience with assay techniques, instrumentation, and data analysis. * Excellent problem-solving, communication, and teamwork skills. *Salary & Benefits* * Salary: $90,000 – $110,000, depending on experience. * Benefits: Medical, dental, life insurance, short- and long-term disability, and a 401(k) plan with 4% employer match. * Paid Time Off: 3 weeks’ vacation (accrued), 9 sick days, 1 floating holiday, and 10 paid holidays. * Benefits begin the first of the month following your hire date. *Why Join Lumos* At Lumos Diagnostics, your science makes a direct impact. You’ll be part of a collaborative and innovative team that values ownership, integrity, and moving forward together. With clear career growth pathways, you’ll have the opportunity to advance your skills and contribute to meaningful healthcare solutions. Job Type: Full-time Pay: $90,000.00 - $110,000.00 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Employee discount * Flexible spending account * Health insurance * Health savings account * Life insurance * Paid parental leave * Paid time off * Referral program * Vision insurance Education: * Bachelor's (Preferred) Experience: * Laboratory: 5 years (Required) * GMP: 5 years (Required) * ISO 13485: 5 years (Required) * Assays: 5 years (Required) * Aseptic technique: 5 years (Required) Location: * Carlsbad, CA 92010 (Required) Shift availability: * Day Shift (Required) Ability to Commute: * Carlsbad, CA 92010 (Required) Ability to Relocate: * Carlsbad, CA 92010: Relocate before starting work (Required) Work Location: In person
Job Information Number ICIMS-2025-9110 Job function Manufacturing Job type Full-time Location San Diego - WBH - 6260 Sequence Drive San Diego, California 92121 United States Country United States Shift 1st About the Position Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview Job Summary The Manufacturing Maintenance Engineer is a senior level mechanical position, that primarily performs complex mechanical and electrical repairs to automated and semi-automated machinery. Specializing in detailed diagnostics of machine issues, utilizing schematics and detailed knowledge of mechanical principles. Ensures the efficient operation of equipment in manufacturing processes, focusing on continuous process and machine improvements. The salary range for this position is currently $125,000-$150,000 annually. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs. Responsibilities Key Accountabilities Subject matter expert in all mechanical and electrical systems, related functions and automated machines, including HVAC systems, and lyophilizing equipment. Oversee and carry out the diagnoses and repair of automated machinery. Utilize diagnostic tools and techniques to identify and resolve complex mechanical problems. Carry out work safely per OSHA regulated guidelines, and established safety procedures. Ensure compliance of FDA, ISO, OSHA, and GMP regulations and standards in regards to maintenance actions. Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs. Maintain accurate records of maintenance and repairs, prepare reports, and communicate effectively with management and other team members. Work to identify improvements for cost and manual labor reduction, and to improve process/equipment yields; work with management to implement identified improvements. Support and drive change within the operation by establishing partnerships with peers, cross functional stakeholders, assigned staff and shop floor colleagues to align their actions with the process improvement efforts. Support daily production activities and goals; continuously work to ensure mechanical performance of equipment that supports timely release of product and avoids back orders. Support the installation, qualification, and validation of new equipment and processes. Support the engineering staff, R&D, and manufacturing operations personnel as required. Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures, and processes. Make recommendations for efficiency improvements, equipment purchases, and facility upgrades. Interface with regulatory agencies for site audits if called upon. Other duties as assigned. Networking/Key relationships Manufacturing Production Manufacturing Engineering External Vendors R&D Qualifications Minimum Knowledge and Experience: Bachelor’s degree in engineering. Minimum of ten (10) years of mechanical and electrical experience in a regulated medical device manufacturing or pharmaceutical environment. HVAC and lyophilizing system experience, including repairs and a proven ability to diagnose system issues. Experience with vision systems (e.g., Cognex) and PLC programming/software, including Allen-Bradley and Mitsubishi platforms. Experience in managing Nonconformances (NCs) and Corrective and Preventive Actions (CAPAs). Skills & Capabilities: Bachelor’s degree in technical background or equivalent work experience required. Minimum of ten (10) years of mechanical and electrical experience in a regulated medical device manufacturing or pharmaceutical environment. HVAC and lyophilizing system experience, including repairs and a proven ability to diagnose system issues. Demonstrated high level of competency with automation assembly, including electrical and pneumatic installation/operation. Proficient ability to utilize mechanical diagnostic equipment including calipers, micrometers, gauges, humidity and temperature measuring devices. Proficient ability to utilize electrical diagnostic equipment including multimeters, voltmeters, ohmmeter, wattmeter, and related instruments. Expert in mechanical and electrical theory. Self-motivated with the ability to work independently and as part of a team. Must have a high understanding of electrical and mechanical schematics. Familiarity with GDP, GMP, Food and Drug Administration (FDA), ISO 17025, ISO 9000, and Occupational Safety and Health Administration (OSHA). Working knowledge of Microsoft Office Suite. The ability to communicate effectively with various departments within the company to achieve key performance targets. Work with vendors to source machine components, and on-site repairs. Report on management of any issues that affect production output or safety. If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [email protected] for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com
Who are we: Magnaflow is a leading manufacturer and supplier based in Oceanside, CA of premium products to the automotive aftermarket industry such as catalytic converters, performance exhaust and replacement exhaust. Through the Camburg division in Huntington Beach, CA. Magnaflow also supplies race-inspired performance suspension products and vehicle uplifting services, Magnaflow is focused on future growth through both new business development and new product introduction. our websites are www.magnaflow.com and www.camburg.com. Salary Range: $21.50-$27.50 USD Hourly *Final agreed upon compensation will be based on a variety of factors including but not limited to an individual’s related experience, education, certifications, skills, and work location. What you will be doing: Welder is responsible for welding metal components and structures in a manufacturing environment. The role involves using various welding techniques to join, fabricate, and repair metal parts. Responsibilities: Perform welding tasks using various methods (MIG, TIG, Stick, or Flux Core) to join metal parts according to blueprints, diagrams, or specifications. Inspect completed welds for quality, ensuring they meet company standards and safety regulations. Maintain and operate welding machines, tools, and safety equipment, ensuring they are in good working order. Perform welding repairs on defective parts or products and rework parts that don't meet quality standards. Follow safety procedures, use personal protective equipment (PPE), and ensure the work environment adheres to safety regulations. Work closely with other welders, machinists, and production team members to meet production goals and deadlines. Continuously improve skills and stay updated on new welding techniques and technologies. This position ensures the accuracy or products being welded by placing them into an approved welding fixture and inspecting for fitment to the fixture prior to welding. Welding of stainless-steel products and is familiar with the MIG welding process. This position requires knowledge in proper care, and maintenance of all standard welding equipment, such as changing tips when necessary, and cleaning of the machine. This position requires checking quantities of parts produced for accuracy. Able to adjust to new methods of automation which require nonconventional practices with regards to manufacturing. Inspection parts produced to the company’s quality standards, and fitment to approved measurement devices. Must be able to read drawings, and other manufacturing documents Perform other duties as required Requirements: This position requires an individual who is experienced in welding stainless-steel products and is familiar with the MIG welding process. A minimum of 5 years is preferred. This position requires a basic knowledge of OSHA safety regulations. Maintain accurate counts of parts produced daily. Maintain a functional work area that is consistent with Five “S” and Lean Manufacturing principles. Inspect parts produced to the company’s quality standards, and fitment to the fixture. Close and general vision. Good hand eye coordination. This position requires prolonged standing of up to 8 hours at a time. This position requires the lifting of 50 lbs. Any lifting over 50 lbs. is to be lifted with the assistance of other individuals. This position requires reaching above and below the shoulders. Welding helmet. PPE (Steel toe shoes, safety glasses, gloves, earplugs, etc.) Physical Requirements: Must be able to work on feet all day, climb stairs occasionally, and lift 50 pounds with or without accommodations. What’s in it for you? Competitive Salary PTO, Sick Pay, Birthday Holiday, Paid Holidays Medical, Dental, Vision 401k Matching (Up to 5%) Education assistance Company sponsored events Growing department and team
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Overview: Job Summary The Manufacturing Maintenance Engineer is a senior level mechanical position, that primarily performs complex mechanical and electrical repairs to automated and semi-automated machinery. Specializing in detailed diagnostics of machine issues, utilizing schematics and detailed knowledge of mechanical principles. Ensures the efficient operation of equipment in manufacturing processes, focusing on continuous process and machine improvements. The salary range for this position is currently $125,000-$150,000 annually. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs. Responsibilities: Key Accountabilities Subject matter expert in all mechanical and electrical systems, related functions and automated machines, including HVAC systems, and lyophilizing equipment. Oversee and carry out the diagnoses and repair of automated machinery. Utilize diagnostic tools and techniques to identify and resolve complex mechanical problems. Carry out work safely per OSHA regulated guidelines, and established safety procedures. Ensure compliance of FDA, ISO, OSHA, and GMP regulations and standards in regards to maintenance actions. Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs. Maintain accurate records of maintenance and repairs, prepare reports, and communicate effectively with management and other team members. Work to identify improvements for cost and manual labor reduction, and to improve process/equipment yields; work with management to implement identified improvements. Support and drive change within the operation by establishing partnerships with peers, cross functional stakeholders, assigned staff and shop floor colleagues to align their actions with the process improvement efforts. Support daily production activities and goals; continuously work to ensure mechanical performance of equipment that supports timely release of product and avoids back orders. Support the installation, qualification, and validation of new equipment and processes. Support the engineering staff, R&D, and manufacturing operations personnel as required. Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures, and processes. Make recommendations for efficiency improvements, equipment purchases, and facility upgrades. Interface with regulatory agencies for site audits if called upon. Other duties as assigned. Networking/Key relationships Manufacturing Production Manufacturing Engineering External Vendors R&D Qualifications: Minimum Knowledge and Experience: Bachelor’s degree in engineering. Minimum of ten (10) years of mechanical and electrical experience in a regulated medical device manufacturing or pharmaceutical environment. HVAC and lyophilizing system experience, including repairs and a proven ability to diagnose system issues. Experience with vision systems (e.g., Cognex) and PLC programming/software, including Allen-Bradley and Mitsubishi platforms. Experience in managing Nonconformances (NCs) and Corrective and Preventive Actions (CAPAs). Skills & Capabilities: Bachelor’s degree in technical background or equivalent work experience required. Minimum of ten (10) years of mechanical and electrical experience in a regulated medical device manufacturing or pharmaceutical environment. HVAC and lyophilizing system experience, including repairs and a proven ability to diagnose system issues. Demonstrated high level of competency with automation assembly, including electrical and pneumatic installation/operation. Proficient ability to utilize mechanical diagnostic equipment including calipers, micrometers, gauges, humidity and temperature measuring devices. Proficient ability to utilize electrical diagnostic equipment including multimeters, voltmeters, ohmmeter, wattmeter, and related instruments. Expert in mechanical and electrical theory. Self-motivated with the ability to work independently and as part of a team. Must have a high understanding of electrical and mechanical schematics. Familiarity with GDP, GMP, Food and Drug Administration (FDA), ISO 17025, ISO 9000, and Occupational Safety and Health Administration (OSHA). Working knowledge of Microsoft Office Suite. The ability to communicate effectively with various departments within the company to achieve key performance targets. Work with vendors to source machine components, and on-site repairs. Report on management of any issues that affect production output or safety.