Production Engineer

• Design, develop, and implement engineering solutions to support product and process requirements.
• Create and execute test procedures and develop fixtures for product characterization, experimentation, and production validation.
• Analyze and interpret test data to guide design improvements and ensure product performance and reliability.
• Provide hands-on support for device manufacturing and production processes.
• Prepare detailed reports and technical documentation in compliance with Good Documentation Practices (GDP).
• Maintain, qualify, and implement new manufacturing-related equipment and tooling as needed.
• Ensure proper documentation and traceability of all technical data in accordance with established engineering policies and procedures.
• Perform calibration and preventive maintenance activities on equipment and tools used in device production.
• Collaborate with engineering, manufacturing, and quality teams to ensure adherence to quality standards and regulatory requirements.
• Develop and implement inspection, testing, and evaluation procedures to verify product and equipment precision and accuracy.
• Conduct first-article inspections and establish incoming inspection methods and acceptance criteria.
• Prepare and maintain quality assurance documentation, including CAPAs, NCRs, complaint analyses, and technical reports such as Clinical Evaluation Reports (CERs).
• Develop and document processes for sub-assembly and final product inspection and testing.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analyses to assess product and material conformance.
• Support quality initiatives across design, incoming material inspection, production control, product evaluation, reliability testing, inventory control, and research and development.
• Perform other duties as assigned to support departmental and organizational goals.

• Education
  • Bachelor’s degree in Engineering or a related technical field (required).
  • Background in chemistry or related sciences preferred, with familiarity in analytical techniques such as titrations, dilutions, and general wet lab procedures.
  • Knowledge of laboratory safety standards and practices (GMP/GLP).
• Experience
  • Prior research, co-op, internship, or industry experience preferred.
  • Experience in the medical device industry and familiarity with regulatory standards such as ISO 13485, MDSAP, and MDD is highly desirable.
• Skills and Competencies
  • Strong verbal, written, and electronic communication abilities.
  • Effective problem-solving and critical-thinking skills.
  • Ability to communicate professionally with internal and external stakeholders through phone, email, and in-person interactions.
  • Skilled in delivering presentations to both small and large groups.
  • Proficient in standard software applications, including Microsoft Word and Excel.

• Must be able to sit, stand, walk, and move between office, laboratory, and production areas as job duties requir
• Ability to lift, carry, push, or pull up to 25 pounds occasionally.
• Frequent use of hands and fingers to operate computers, tools, instruments, and testing equipment.
• Requires close vision, color vision, depth perception, and the ability to adjust focus.
• May involve extended periods of computer work and/or microscope or instrument use.
• Occasional bending, stooping, or reaching as needed to perform testing or maintenance tasks.

• Work is primarily performed in an office, laboratory, and/or manufacturing setting.
• May be exposed to moderate noise levels from equipment, machinery, and tools in production or lab areas.
• Occasional exposure to chemicals, biological materials, or other controlled substances may occur; appropriate personal protective equipment (PPE) must be worn.
• Work may involve interaction with production floor personnel, engineering teams, and quality assurance staff in both cleanroom and general manufacturing environments.
• The position may require adherence to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and all applicable safety procedures.

• Comprehensive Health Coverage: Medical, dental, and vision insurance for you and your dependents.
• Time Off: Generous PTO policy and paid holidays
• Retirement Plans: 401(k) with company matching to help you plan for the future.
• Wellness Support: Mental health resources and wellness programs.
• Team Connection: Regular team events, retreats, and gatherings to build community.

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