Quality Engineer – Process Development

We are seeking a Design Quality Engineer – Process Development for a very important client in the diabetes medical device space. This role will support new product introduction, process validation, design transfer, production scale-up, PFMEA, risk management, and CAPA activities for complex medical device manufacturing programs.

About the Role

This is a strong opportunity for a quality engineering professional with hands-on experience in medical devices, FDA QSR, ISO 13485, ISO 14971, IQ/OQ/PQ, TMV, Minitab, DOE, and process validation.

Responsibilities

• Support NPI and production scale-up activities for diabetes medical device products.
• Develop and execute process validation strategies, including IQ/OQ/PQ, TMV, EQV, process characterization, and validation documentation.
• Lead and facilitate PFMEA / FMEA / FMECA activities for manufacturing processes.
• Support design transfer from R&D into manufacturing and contract manufacturing environments.
• Develop P-Diagrams, IPO matrices, DOE plans, process parameters, and control strategies.
• Conduct root cause investigations using A3 Problem Solving, 5-Why, fishbone diagrams, CAPA, and risk-based analysis.
• Partner with Supplier Quality, R&D, NPI teams, Contract Manufacturers, and Design Quality Assurance.
• Review drawings and ensure critical dimensions are reflected in inspection plans and quality controls.
• Use Minitab for statistical analysis, including hypothesis testing, tolerance intervals, capability analysis, regression, DOE, GR&R, SPC, and I-MR charts.
• Identify and resolve production risks, manufacturing issues, and production holds during commercialization.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related engineering field with 7 years of relevant experience or Master’s degree with 5 years of relevant experience.
• Experience in medical device quality engineering, process development, manufacturing engineering, or process validation.
• Strong background with NPI, design transfer, production scale-up, and process validation.
• Hands-on experience with IQ/OQ/PQ, TMV, PFMEA, DFMEA, CAPA, root cause analysis, and risk management.
• Experience working under FDA QSR, ISO 13485, ISO 14971, EU MDR, GMP, and related regulatory frameworks.
• Strong statistical analysis experience using Minitab.
• Experience working cross-functionally with R&D, Supplier Quality, Contract Manufacturers, and Manufacturing teams.

Preferred Skills

• Experience with CGM, Continuous Glucose Monitoring, insulin pumps, diabetes devices, or wearable medical devices.
• Experience resolving production holds or scale-up challenges during NPI commercialization.
• Experience working with contract manufacturers and external suppliers.
• CQE, Six Sigma Green Belt, Six Sigma Black Belt, or similar certification.

Experience with automated manufacturing lines and assembly-level process optimization.