Principal Quality Engineer

Frontseat Partners; Pittsburgh (Allegheny County); On-site; USD 110,000 - 140,000; Full time

Job summary

Frontseat Partners is seeking a Principal Quality Engineer for Design & R&D Quality in Pittsburgh, on-site. You will take ownership of design controls and DHF, partnering with R&D and Engineering to drive development from concept through verification and commercialization.

The role requires 4–8+ years of medical device quality experience, strong design controls, risk management, V&V, and knowledge of ISO 13485 and FDA QSR.

Qualifications

• 4–8+ years of medical device quality experience.
• Strong Design Controls, DHF and R&D/product quality expertise.
• Good understanding of the medical device development lifecycle.
• Experience with risk management, V&V and design changes.
• Knowledge of ISO 13485 and FDA Quality System requirements.
• Ability to operate independently and work closely with technical teams.
• Availability to work on-site in Pittsburgh.

Responsibilities

• Own and strengthen Design Controls and Design History Files (DHF).
• Partner closely with R&D and Engineering throughout product development.
• Support requirements, risk management, V&V, design reviews and design changes.
• Ensure design documentation is compliant, traceable and inspection-ready.
• Support commercial, clinical-stage and new development programs.
• Improve and scale Quality processes as the product portfolio grows.
• Collaborate across Quality, Regulatory, Engineering and Manufacturing.

Skills

Design Controls

DHF

R&D QA

Risk Management

V&V

Design Changes

ISO 13485

FDA QSR

Job description

Principal Quality Engineer – Design & R&D Quality

Medical Devices | Design Controls | Product Quality | R&D

Location: Pittsburgh, PA | On-site

Our client is an innovative MedTech company developing next-generation medical devices. With a commercial product already on the market, others in clinical trials and a growing development pipeline, the company is looking for an experienced Quality professional to take a key position within its R&D and Quality organization.

This is a hands-on Design & R&D Quality role with significant ownership and the opportunity to become the right hand to the Quality Director for Design Quality.

The opportunity

You will play a central role in Quality activities supporting products from early development through verification, validation and commercialization.

• Own and strengthen Design Controls and Design History Files (DHF)
• Partner closely with R&D and Engineering throughout product development
• Support requirements, risk management, V&V, design reviews and design changes
• Ensure design documentation is compliant, traceable and inspection-ready
• Support commercial, clinical-stage and new development programs
• Improve and scale Quality processes as the product portfolio grows
• Collaborate across Quality, Regulatory, Engineering and Manufacturing

While the initial focus is Design Quality / R&D Quality, the role offers the opportunity to broaden your expertise into Regulatory, CAPA, audits, manufacturing and wider Quality Systems.

Who we are looking for

Ideally, you bring:

• 4–8+ years of medical device Quality experience
• Strong Design Controls, DHF and R&D/Product Quality expertise
• Good understanding of the medical device development lifecycle
• Experience with risk management, V&V and design changes
• Knowledge of ISO 13485 and FDA Quality System requirements
• Ability to operate independently and work closely with technical teams
• Availability to work on-site in Pittsburgh

This is particularly suited to someone who wants more ownership, broader exposure and direct access to Quality leadership.

Growing product pipeline. High-impact role. Broad Quality exposure. Clear leadership potential.

You’ll have the opportunity to make a visible impact on Design Quality while expanding your experience across the wider Quality and Regulatory function.

For the right person, there is a clear path toward managerial and leadership responsibilities as the organization continues to grow.