Product Development Engineer

Staftonic LLC; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

Staftonic LLC is seeking an experienced medical device engineer to lead product and design changes from feasibility through manufacturing implementation. The role emphasizes design controls, risk management, and verification activities across the development lifecycle.

You will develop, validate, and execute test methods and protocols, support IQ/OQ/PQ activities, and maintain engineering documentation. Expect hands-on work on the factory floor and collaboration with multiple teams, including

Qualifications

• 5–7+ years of hands-on medical device engineering/product development experience.
• Strong experience with medical device design and development in a regulated environment.
• Experience taking design changes from concept/prototype through verification and production.

Responsibilities

• Lead design changes from feasibility and prototyping through DV and manufacturing implementation.
• Apply Design Controls, DHF, Risk Management, and FMEA throughout the product development lifecycle.
• Develop, validate, and execute test methods, simulated-use testing, and verification protocols.
• Support IQ/OQ/PQ activities as applicable.
• Create and maintain engineering drawings, specifications, test protocols, reports, and other technical documentation.
• Work directly on the manufacturing floor and in the laboratory to troubleshoot product and process issues.
• Collaborate with manufacturing, quality, R&D, and engineering teams to resolve technical issues and implement design improvements.
• Communicate project status, technical risks, engineering decisions, and recommendations to engineering stakeholders.
• Provide technical direction and review work performed by an offshore engineering team.

Skills

Medical device engineering

Design controls

FMEA

IQ/OQ/PQ

CAD - SolidWorks/Creo

Regulatory environment

Troubleshooting

Tools

SolidWorks

Creo

Job description

• Lead product/design changes from feasibility and prototyping through design verification (DV) and manufacturing implementation.
• Apply Design Controls, DHF, Risk Management, and FMEA throughout the product development lifecycle.
• Develop, validate, and execute test methods, simulated-use testing, and verification protocols.
• Support and execute IQ/OQ/PQ activities as applicable.
• Create and maintain engineering drawings, specifications, test protocols, reports, and other technical documentation.
• Work directly on the manufacturing floor and in the laboratory to troubleshoot product and process issues.
• Collaborate with manufacturing, quality, R&D, and engineering teams to resolve technical issues and implement design improvements.
• Communicate project status, technical risks, engineering decisions, and recommendations to engineering stakeholders.
• Provide technical direction and review work performed by an offshore engineering team.

Required Qualifications:

• 5–7+ years of hands-on medical device engineering/product development experience.
• Strong experience with medical device design and development in a regulated environment.
• Experience taking design changes from concept/prototype through verification and production.
• Strong knowledge of design controls, DHF, risk management, FMEA, and design verification.
• Experience developing and validating engineering test methods.
• Experience with simulated-use testing and verification testing.
• Familiarity with IQ/OQ/PQ and validation protocols.
• Ability to create, interpret, and maintain engineering drawings, specifications, and technical documentation.
• Strong troubleshooting and problem-solving skills with the ability to work directly with manufacturing and laboratory teams.

Preferred Experience:

• Catheter-based medical devices
• Compliant balloon catheters
• Biopsy needles
• Interventional or minimally invasive medical devices
• Catheter assemblies, delivery systems, guidewires, or similar devices
• Design transfer and manufacturing implementation
• DFM / Design for Manufacturing
• CAD tools such as SolidWorks or Creo
• Experience providing technical guidance to offshore engineering teams