Key Responsibilities
The Manufacturing Technician plays a critical role in the production of clinical and
commercial implantable medical devices. This position is responsible for precision assembly,
chemical processing, and documentation activities that ensure products meet stringent
engineering specifications, quality standards, and regulatory requirements. The role requires
strong fine motor skills, cleanroom discipline, and the ability to execute complex
manufacturing steps with consistency and accuracy.
Essential Job Functions
- Perform precision assembly of medical devices using microscopes, micro tools,
fixtures, and calibrated equipment.
- Follow detailed work instructions, engineering drawings, and process specifications to
ensure all assemblies meet defined tolerances.
- Document all manufacturing activities in batch records, forms, and lab notebooks in
compliance with GDP standards.
- Prepare chemical solutions and support chemical and electrical based processes such
as cleaning, anodizing, or surface treatments.
- Clean and prepare medical device components using established procedures
- Maintain and disinfect cleanrooms, laminar flow hoods, and controlled environments
to support ISO classified operations.
- Operate production equipment such as microscopes, ovens, laser tools, bonding
equipment, semiconductor tools, and metrology instruments.
- Perform in process inspections using microscopes, measurement tools, and test
equipment to verify conformance to specifications.
- Support equipment maintenance, calibration, and troubleshooting in collaboration with
engineering and quality teams.
- Assist in manufacturing prototype or pilot scale components for R&D and process
development activities.
- Participate in root cause investigations, nonconformance documentation, and
corrective/preventive action activities.
- Identify opportunities for process improvements and contribute to continuous
improvement initiatives.
- Perform other duties as assigned to support production and operational needs
Requirements
Minimum Qualifications and Education Requirements
- Associate degree or equivalent experience in a technical, scientific, or engineering discipline
- Minimum of 2 years of experience in medical device, biotech, semiconductor, or other high precision manufacturing environments
- Demonstrated fine motor skills and manual dexterity for handling micro scale components
- Strong attention to detail and ability to follow complex, multi step procedures
- Proficiency with pipettes, laboratory equipment, and basic wet chemistry techniques
- Proficiency in Microsoft Excel
- Strong verbal and written communication skills
- Solid understanding of GDP and documentation practices in regulated environments
Preferred Qualifications And Skills
- Experience in GMP regulated manufacturing (ISO 13485, 21 CFR Part 820)
- Background in Class II or Class III implantable medical device assembly
- Experience with aseptic technique, sterile assembly, or cleanroom gowning (ISO 7/8)
- Familiarity with micro fabrication, laser processing, or semiconductor processing
- Working knowledge engineering principles relevant to manufacturing
- Familiarity with Lean or Six Sigma principles (e.g., waste reduction, root cause analysis, standard work) and ability to apply them to daily manufacturing tasks
- Ability to apply critical thinking to troubleshoot process deviations or equipment issues
Physical and Environmental Demands
- Ability to stand, walk, sit, reach, balance, or stoop for extended periods
- Fine motor skills and dexterity required for micro assembly and handling delicate components
- Ability to lift up to 25 lbs
- Ability to visually inspect small parts under magnification for extended periods
Working Conditions
- Frequent work in cleanrooms and controlled environments, often in close proximity to others
- Work in laboratory hoods where fumes or chemical vapors may be present
- Exposure to hazardous or toxic chemicals with required PPE
Salary Range: $75,000 - 95,000
Final compensation will be determined based on job‑related factors such as experience, education, and training.
Benefits
- Medical
- Dental and Vision
- Flexible Spending Account (FSA)
- 401K with Company Safe Harbor Match: 100% /up to 4%
- Life Insurance
- Long Term Disability
- Home Office Stipend
- Commuter benefits
