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 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 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. 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 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. 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 elevate 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. #J-18808-Ljbffr Planet Pharma Group