Senior Product Development Engineer

Eureka Infotech Inc; Winston-Salem (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Eureka Infotech Inc. in Winston-Salem, NC is seeking an experienced medical device engineer to own design changes from concept through verification and into production, with on-site presence on the factory floor.

You will apply design controls and risk management across the product lifecycle, develop validation strategies, and collaborate with client stakeholders and an offshore team to deliver robust devices on schedule.

Qualifications

• 5–7+ years of hands‑on experience in medical device engineering.
• Experience with compliant balloon catheters, biopsy needles, or other catheter‑based devices is a strong plus.
• A track record of carrying design changes from concept through verification and into production.
• Working fluency in design controls (DHF), risk management, and test method development and validation.
• Familiarity with simulated‑use testing and installation/operational/performance qualification (IQ/OQ/PQ).
• Comfort producing and reading engineering drawings, specifications, and documentation to the standards of a regulated environment.
• A self‑starter mindset — someone who can take a problem on the floor and see it through without heavy oversight.

Responsibilities

• Take ownership of design changes from feasibility and prototyping through design verification (DV) and into manufacturing implementation.
• Apply design controls, risk management, and structured engineering documentation practices throughout the product development lifecycle.
• Develop and validate test methods, including simulated-use testing and IQ/OQ/PQ protocols, and see them through to execution.
• Produce and maintain accurate drawings, specifications, and supporting engineering documentation.
• Spend meaningful time on the manufacturing floor and in the lab, diagnosing and resolving product and process issues as they arise.
• Act as the primary engineering liaison with client stakeholders, communicating project status, risks, and technical decisions clearly.
• Set technical direction for an offshore engineering team, reviewing their analysis and guiding their work on your programs.

Skills

Medical device engineering

Design controls

Risk management

Documentation practices

Manufacturing floor & lab

Stakeholder communication

Offshore team leadership

Job description

• Take ownership of design changes from feasibility and prototyping through design verification (DV) and into manufacturing implementation.
• Apply design controls, risk management, and structured engineering documentation practices throughout the product development lifecycle.
• Develop and validate test methods, including simulated-use testing and IQ/OQ/PQ protocols, and see them through to execution.
• Produce and maintain accurate drawings, specifications, and supporting engineering documentation.
• Spend meaningful time on the manufacturing floor and in the lab, diagnosing and resolving product and process issues as they arise.
• Act as the primary engineering liaison with client stakeholders, communicating project status, risks, and technical decisions clearly.
• Set technical direction for an offshore engineering team, reviewing their analysis and guiding their work on your programs.

Qualifications

• 5–7+ years of hands‑on experience in medical device engineering.
• Experience with compliant balloon catheters, biopsy needles, or other catheter‑based devices is a strong plus.
• A track record of carrying design changes from concept through verification and into production.
• Working fluency in design controls (DHF), risk management, and test method development and validation.
• Familiarity with simulated‑use testing and installation/operational/performance qualification (IQ/OQ/PQ).
• Comfort producing and reading engineering drawings, specifications, and documentation to the standards of a regulated environment.
• A self‑starter mindset — someone who can take a problem on the floor and see it through without heavy oversight.

Where You’ll Work

This position is based onsite in Winston‑Salem, NC. Expect regular time on the manufacturing floor and in the lab, along with frequent, direct interaction with client engineering stakeholders and the offshore engineering team you’ll be guiding.