Senior Manufacturing Engineer

Senior Manufacturing Engineer – Medical Devices

Overview:

Lead the development, optimization, validation, and sustainment of manufacturing processes for regulated medical devices. Collaborate with R&D, Quality, Regulatory, Supply Chain, and Production teams to ensure safe, compliant, and cost-effective manufacturing throughout the product lifecycle.

Key Responsibilities:

• Develop, optimize, and validate manufacturing processes for new and existing devices.
• Support product transfer from R&D to manufacturing (NPI, scale-up, commercialization).
• Implement process improvements to enhance yield, quality, safety, and throughput.
• Plan and execute process validation (IQ/OQ/PQ) and apply statistical tools (SPC, DOE).
• Standardize processes, workstations, and equipment use; guide supplier selection and performance.
• Lead risk assessments (FMEA/pFMEA), CAPA, NCMR, and deviation investigations.
• Act as technical liaison for contract manufacturers and internal engineering teams.
• Create test protocols, analyze data, and generate design verification reports.
• Support Lean, Six Sigma, or Operational Excellence initiatives.

Qualifications:

• Bachelor’s degree in Mechanical, Manufacturing, Biomedical, or related Engineering field.
• 5+ years in medical device manufacturing, product development, or process engineering.
• Experience with ultrasonic welding, injection molding, circuit boards, calibration equipment, and process validation.
• Proficient in CAD, fixture design, and statistical process control.
• Knowledge of risk management, process controls, and working with contract manufacturers.
• Lean/Six Sigma certification preferred; startup experience a plus.
• Strong communication skills and ability to work independently and cross-functionally.