Design Quality Engineer

Are you a Design Quality Engineer with a passion for new product introduction, process validation, and risk management within the medical device industry? We are seeking experienced engineers to support the development, validation, and commercialization of innovative diabetes care technologies.

In this highly visible role, you will serve as a key quality partner throughout product development and production scale-up activities, ensuring manufacturing processes are robust, compliant, and ready for commercial launch. This position offers the opportunity to work closely with R&D, Supplier Quality, Contract Manufacturers, and Operations teams while driving quality excellence in a regulated medical device environment., * Develop process characterization strategies, P-Diagrams, Input-Process-Output (IPO) matrices, and Test Method Validation (TMV) plans.

• Author and execute validation protocols including IQ, OQ, PQ, EQV, and TMV activities.
• Support New Product Introduction (NPI) programs and production scale-up initiatives.
• Apply Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Manufacturing and Assembly (DFMA), and Cell Operating System (COS) methodologies.
• Drive risk mitigation strategies early in process development.

Process Risk Management

• Lead and facilitate Process Failure Mode and Effects Analysis (PFMEA) activities.
• Review and interpret design risk documentation including DFMEA, Risk Analysis Documents (RAD), and Hazard Risk Assessments (HRA).
• Identify process risks with potential design implications and partner with Design Quality teams to drive resolution.
• Conduct root cause investigations utilizing A3 Problem Solving, Fishbone Diagrams, 5-Why Analysis, and other structured methodologies.

Cross-Functional Leadership

• Act as the primary quality representative between Supplier Quality, R&D, Contract Manufacturers, Operations, and NPI teams.
• Collaborate on design transfer activities to ensure manufacturability and successful commercialization.
• Align internal and external partners on control plans, inspection criteria, validation requirements, and quality expectations.
• Drive comprehensive drawing reviews to ensure critical dimensions and inspection requirements are properly defined.

Production Scale-Up & Commercialization

• Support high-volume production ramp-up and commercialization efforts.
• Lead investigations and resolution efforts during production holds and manufacturing challenges.
• Develop and implement CAPAs to address process and supplier-related issues.
• Proactively identify and mitigate manufacturing risks that could impact launch timelines.

Statistical Analysis & Continuous Improvement

• Perform statistical analysis using Minitab, including:
• DOE (Design of Experiments)
• GR&R Studies
• Capability Analysis
• Hypothesis Testing
• Confidence & Tolerance Intervals
• Regression Analysis
• Statistical Process Control (SPC)
• Utilize data-driven approaches to improve process performance and product quality.

Do you have a valid Certified Quality Engineer certification?, Do you have experience in Test validation method?, * Bachelor’s Degree in Engineering or related technical discipline.

• 4+ years of medical device quality engineering, process development, or manufacturing quality experience.
• 4+ years of experience developing and executing process validation strategies (IQ/OQ/PQ/TMV).
• 4+ years facilitating and generating PFMEA documentation.
• Strong knowledge of DFMEA, design risk management, and risk assessment methodologies.
• Experience developing process parameters, process characterizations, P-Diagrams, IPO matrices, and DOE strategies.
• Proficiency with Minitab and advanced statistical analysis techniques.
• Experience supporting Design Control, Design Verification, Process Validation, CAPA, and root cause investigations.
• Working knowledge of:
• FDA Quality System Regulations (QSR)
• ISO 13485
• ISO 14971
• ISO 11135
• ISO 11737
• EU MDR
• Experience working cross-functionally with Supplier Quality, R&D, Manufacturing, Contract Manufacturers, and NPI teams.
• Strong understanding of GMP requirements and FMECA methodologies., * Experience supporting Continuous Glucose Monitoring (CGM) systems, insulin pumps, or diabetes-related medical devices.
• Experience leading production scale-up and commercialization activities.
• Experience supporting contract manufacturing organizations and design transfer projects.
• Proven ability to resolve production holds and critical manufacturing issues during product launch.
• CQE (Certified Quality Engineer) certification.
• Six Sigma Black Belt certification.
• Experience with automated manufacturing lines and assembly process optimization.

What We’re Looking For

• Strong technical problem solver who thrives in fast-paced NPI environments.
• Proven leader capable of driving cross-functional alignment and quality decision-making.
• Comfortable navigating ambiguity and resolving complex manufacturing challenges.
• Passionate about delivering safe, effective, and high-quality medical devices that improve patient outcomes.

Pulled from the full job description

• Vision insurance
• Dental insurance
• Life insurance
• Disability insurance
• Commuter assistance