New Product Development (NPD) Quality Engineer

Company Description

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ProPlate® 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.

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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.

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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.

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

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What You’ll Do

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

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

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• Bachelor’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or a related technical discipline
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• 3–5+ years of Quality Engineering experience within medical device manufacturing or another regulated industry
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• Hands-on experience supporting New Product Development (NPD), Design Transfer, Manufacturing Transfer, and Process Validation
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• Experience developing and executing IQ/OQ/PQ validation activities
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• Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, GMP requirements, and applicable medical device quality requirements
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• Working knowledge of FMEA, DOE, Gauge R&R/MSA, SPC, process capability, CAPA, and root cause investigation
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• Proficiency with statistical software such as Minitab or JMP
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• Strong project management, analytical, organizational, and problem-solving skills
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• Effective written and verbal communication skills
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• Ability to manage multiple priorities in a fast-paced development and manufacturing environment
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Preferred Qualifications

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• Experience working directly with customers in a CDMO or contract manufacturing environment
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• Experience with medical device new product introduction (NPI) and phase-gate development processes
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• Experience with APQP, PPAP, TMV, and CSV
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• Experience with Keyence systems, profilometers, XRF, laser measurement systems, vision systems, measurement system programming, or automated inspection technologies
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• Experience with plating, surface finishing, or advanced coatings for medical devices
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• Experience with software validation and electronic quality management systems (eQMS)
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• Lean Six Sigma certification or hands-on continuous improvement experience
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• Certified Quality Engineer (CQE) certification
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• Knowledge of cleanroom manufacturing and sterilization processes
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• PLC programming experience, including Rockwell Automation/Allen-Bradley or Siemens, is a plus
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Work Environment

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• Hands-on role with regular interaction across Engineering, Quality, and manufacturing operations
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• Exposure to production and plating environments requiring adherence to applicable safety and hygiene requirements
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• Occasional travel may be required to customer, supplier, or other company locations
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Compensation & Benefits

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• Competitive salary based on experience and qualifications
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• Medical insurance
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• 401(k) with company match
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• Paid time off (PTO)
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• Paid holidays
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• HSA or FSA
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• Flexible work schedule where applicable
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• Professional development and career growth opportunities
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• Collaborative, team-oriented culture with exposure to cutting-edge medical device technologies
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