Quality Engineer - Process Development

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 crossfunctional 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

OR

• 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