Quality Engineer

Quality Engineer

Design Quality Engineer — Process Development to support new product introduction (NPI) and production scale-up activities within the diabetes medical device space. This individual will drive process validation strategies, lead process risk management (PFMEA), and serve as a critical cross-functional liaison between internal Supplier Quality, R&D, Contract Manufacturers, and NPI teams. The ideal candidate brings deep expertise in process development, FMEA methodologies, and regulatory compliance — A proven track record of resolving critical production issues during scale-up and mentoring engineering teams is essential.

Process Development & Validation

• Develop P-diagrams, Input-Process-Output (IPO) matrices, process characterizations, and test method validation (TMV) strategies for NPI programs.
• Author and manage Master Validation documents (IQ/OQ/PQ/EQV/TMV) for new product introductions and production scale-up.
• Apply methodologies including Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing Assembly (DFMA), and Cell Operating System (COS).
• Drive risk mitigation approaches by integrating qualification parts early in process development phases

Process Risk Management & Risk Navigation

• Facilitate and generate Process Failure Modes Effects Analysis (PFMEA) documents for manufacturing processes during NPI and scale-up.
• Maintain strong working knowledge of design risk documentation (RAD, DFMEA, HRA) to critically analyze process-related failures and identify gaps.
• Recognize when process findings have design risk implications and escalate appropriately to Design Quality Assurance (DQA) partners for design risk assessment decisions.
• Leverage understanding of risk documentation during root cause investigations and critical analyses to ensure comprehensive disposition.
• Conduct thorough root cause investigations using A3 Problem Solving methodology, fishbone diagrams, 5-Why analysis, and brainstorming techniques

Cross-Functional Engagement & Collaboration

• Serve as the primary quality interface between internal Supplier Quality Engineering (SQE), R&D cross-functional teams, Contract Manufacturers, and NPI program teams.
• Facilitate regular cadence of alignment discussions with Supplier Quality and vendors to implement updated control plans, inspection criteria, and risk documentation.
• Collaborate with R&D teams to translate design intent into manufacturable process parameters during design transfer.
• Partner with NPI groups to ensure seamless transition from development builds through production qualification and commercial readiness.
• Ensure alignment between contract manufacturers and internal teams on deliverables, expectations, and quality standards.
• Bridge QMS gaps between contract manufacturing partners and internal quality systems, standardizing documentation templates and expectations.
• Direct comprehensive drawing reviews with cross-functional partners ensuring all Critical Dimensions are accounted for incoming and in-process inspections.

Production Scale-Up Support & Crisis Management

• Lead cross-functional teams through high-pressure production holds and scale-up challenges during NPI commercialization.
• Conduct root cause investigations (A3 methodology) and implement Corrective and Preventive Actions (CAPA).
• Strategize and guide engineering teams to deploy effective investigation approaches for supplier and manufacturing issues.
• Proactively identify production risks during scale-up and drive containment/resolution before they impact launch timelines.

Statistical Analysis & Data-Driven Decision Making

• Perform statistical analyses including hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, and GR&R using Minitab.
• Utilize statistical process control (SPC), I-MR charts, Box plots, and Normality & No

Required Skills & Qualifications

• 4+ years applying DRM, DFSS, DFMA, and COS methodologies in medical device process development
• 4+ years facilitating and generating PFMEA documents; strong working knowledge of DFMEA and design risk documentation (RAD, HRA) sufficient to identify gaps and escalate appropriately
• 4+ years developing process parameters, DOEs, P-diagrams/IPO matrices, process characterizations, and process validation strategies (IQ/OQ/PQ/TMV)
• 4+ years performing statistical analysis (hypothesis testing, confidence/tolerance intervals, regression, capability analysis, DOEs, GR&R) in Minitab
• 4+ years working within FDA QSR, ISO 13485, ISO 14971, ISO 11135, ISO 11737, and EU MDR regulatory frameworks
• 4+ years coordinating Design Control, Design Verification, Process Validation, root cause investigations, and CAPA activities
• Demonstrated experience collaborating cross-functionally with Supplier Quality, R&D, Contract Manufacturers, and NPI teams in a matrixed environment
• Demonstrated experience utilizing Good Manufacturing Practices (GMP) and FMECA

Preferred Qualifications

• Experience with CGM (Continuous Glucose Monitoring) sensors or insulin pump systems
• Proven track record resolving production holds during NPI commercialization and scale-up
• Experience managing design transfer and production scale-up activities with contract manufacturers.
• Experience serving as the quality "bridge" between multiple external partners and internal stakeholders
• Experience with problem-solving methodology
• CQE (Certified Quality Engineer) or Six Sigma Black Belt certification
• Familiarity with automated manufacturing lines and assembly-level process optimization

Required:

• Master's degree in Mechanical Engineering, Biomedical Engineering, or related field AND 5+ years of experience in process development, manufacturing, or quality engineering for medical devices
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering field AND 7+ years of experience in process development, manufacturing, or quality engineering for medical devices