Design Quality Engineer

Pay 50-60/h depending on experience

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.

• 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.

• 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 elevate 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.

• 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.

• 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.

• 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.

• 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…