New Product Development (NPD) Quality Engineer

ProPlate®; Anoka (MN); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Medical insurance

401(k) with company match

PTO

Paid holidays

HSA or FSA

Flexible work schedule

Professional development

Job summary

ProPlate® is seeking a New Product Development Quality Engineer to drive quality for new medical device programs from concept to sustained production.

You will work with Engineering, Operations, and Suppliers on design controls, validation, and manufacturing transfer, using IQ/OQ/PQ, APQP/PPAP, FMEA, SPC, and CAPA to ensure robust product launches.

Qualifications

• Bachelor’s degree in Engineering or related discipline required.
• 3–5+ years of Quality Engineering experience in medical device manufacturing or regulated setting.
• Experience with NPD, Design Transfer, Manufacturing Transfer, and Process Validation.

Responsibilities

• Serve as Quality representative on cross-functional NPD teams.
• Support phase-gate development from POC through validation and transfer to production.
• Lead design controls, reviews, specifications, engineering changes, and customer requirements.
• Coordinate manufacturing transfer activities between development, production, suppliers, and customers.
• Develop and approve validation activities (IQ/OQ/PQ, TMV, CSV) where applicable.
• Support APQP and PPAP activities as needed.
• Facilitate risk management (dFMEA, pFMEA, Control Plans, Hazard Analysis).
• Coordinate process capability studies and use predictive quality to reduce defects.
• Perform Gauge R&R, MSA, Cp/Cpk, SPC, DOE studies and analyze data.
• Lead CAPA investigations using 8D, Fishbone, 5 Whys methodologies.
• Drive Lean Six Sigma improvements in inspection and measurement processes.
• Support supplier qualification and incoming inspection readiness for new products.
• Participate in internal, customer, and regulatory audits.
• Collaborate with Engineering, Operations, and Supply Chain on development and commercialization.

Skills

NPD experience

Design transfer

Process validation

IQ/OQ/PQ

ISO 13485

FMEA

DOE

Gauge R&R

MSA

SPC

CAPA

Root cause

Minitab/JMP

Project management

Communication

Prioritization

Lean Six Sigma

CDMO experience

Education

Bachelor’s degree in Engineering or related

CQE certification

Tools

Minitab

JMP

Job description

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.

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.

What You’ll Do

• 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

What Makes This Role Different

• 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

What We’re Looking For

• 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 or JMP
• Strong project management, analytical, organizational, and problem-solving skills
• Effective written and verbal communication skills
• Ability to manage multiple priorities in a fast‑paced development and manufacturing environment

Preferred Qualifications

• Experience working directly with customers in a CDMO or contract manufacturing environment
• Experience with medical device new product introduction (NPI) and phase-gate development processes
• Experience with APQP, PPAP, TMV, and CSV
• Experience with Keyence systems, profilometers, XRF, laser measurement systems, vision systems, measurement system programming, or automated inspection technologies
• Experience with plating, surface finishing, or advanced coatings for medical devices
• Experience with software validation and electronic quality management systems (eQMS)
• Lean Six Sigma certification or hands‑on continuous improvement experience
• Certified Quality Engineer (CQE) certification
• Knowledge of cleanroom manufacturing and sterilization processes
• PLC programming experience, including Rockwell Automation/Allen‑Bradley or Siemens, is a plus
• Hands‑on role with regular interaction across Engineering, Quality, and manufacturing operations
• Exposure to production and plating environments requiring adherence to applicable safety and hygiene requirements
• Occasional travel may be required to customer, supplier, or other company locations
• Competitive salary based on experience and qualifications
• Medical insurance
• 401(k) with company match
• Paid time off (PTO)
• Paid holidays
• HSA or FSA
• Flexible work schedule where applicable
• Professional development and career growth opportunities
• Collaborative, team‑oriented culture with exposure to cutting‑edge medical device technologies