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.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.