Product Development; NPD) Quality Engineer

Pro Plate® is a leader in engineered metal coating and metallization solutions with over 40 years of expertise serving critical industries, with a strong focus on medical devices. As a Contract Development and Manufacturing Organization (CDMO), we partner with customers from early-stage development through validation, manufacturing transfer, and commercial production.

Our technologies support advanced medical device applications including radiopaque markers, catheter and electrode components, selective metallization, and metallized polymer and balloon structures for energy delivery and sensing.

We are seeking a New Product Development Quality Engineer to play a key role in bringing new medical device programs from concept and proof of concept through validation, manufacturing transfer, and sustained production.

Come join our great company culture and help bring innovative medical technologies to market.

• Serve as the Quality representative on cross-functional new product development teams
• Support programs through phase-gate development from proof of concept (POC) through validation, manufacturing transfer, and sustained production
• Support design controls, design reviews, specifications, engineering changes, and customer-specific quality requirements
• Lead and support manufacturing transfer activities between development, production, suppliers, and customers
• Develop, execute, review, and approve validation activities including IQ/OQ/PQ, TMV, and CSV
  , as applicable
• Support APQP and PPAP activities where required
• Facilitate risk management activities including dFMEA, pFMEA, Control Plans, Hazard Analysis, and Risk Assessments
• Coordinate process capability studies and use predictive quality approaches to reduce downstream defects and nonconformances
• Perform and interpret Gauge R&R, MSA, Cp/Cpk/Ppk, SPC, and DOE studies
• Develop and support measurement system programming and automated inspection methods
• Lead root cause investigations and CAPA activities using structured problem-solving methodologies including 8D, Fishbone, and 5 Whys
• Drive continuous improvement using Lean and Six Sigma methodologies, including opportunities to optimize inspection and measurement processes
• Support supplier qualification and incoming inspection readiness for new and transferred products
• Participate in internal, customer, and regulatory audits
• Analyze quality data and trends to proactively identify and mitigate risk
• Partner directly with Engineering, Operations, Supply Chain, customers, and other key stakeholders throughout product development and commercialization

• NPD-focused Quality role: Work directly on new programs from early development through commercial manufacturing
• Customer-facing CDMO environment: Collaborate directly with medical device customers developing next-generation technologies
• Advanced manufacturing exposure: Work with precision plating, metallization, surface finishing, automated inspection, and specialized measurement technologies
• High-impact ownership: Help define validation strategy, risk controls, measurement systems, and manufacturing readiness
• Cross-functional influence: Partner closely with Engineering and Operations rather than operating solely within a traditional Quality function
• Continuous improvement: Apply statistical, Lean, and predictive quality tools to solve real manufacturing challenges before they reach production

• Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or a related technical discipline
• 3–5+ years of Quality Engineering experience within medical device manufacturing or another regulated industry
• Hands‑on experience supporting New Product Development (NPD), Design Transfer, Manufacturing Transfer, and Process Validation
• Experience developing and executing IQ/OQ/PQ validation activities
• Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, GMP requirements
  , and applicable medical device quality requirements
• Working knowledge of FMEA, DOE, Gauge R&R/MSA, SPC, process capability, CAPA, and root cause investigation
• Proficiency with statistical software such as Minitab…