Principal R&D Compliance Engineer

Principal R&D Compliance Engineer

Hybrid or On-site | Full-Time | Located near Worcester, MA

You are a detail-driven engineer who thrives at the intersection of compliance, innovation, and product excellence. We're conducting a search for a Principal R&D Compliance Engineer to play a critical role in advancing technology that directly impacts patient care.

Key Responsibilities:

• Lead global material planning and contribute to complex R&D solutions while ensuring compliance with industry regulations.
• Partner with cross-functional engineering teams to analyze components, reduce costs, and standardize specifications.
• Oversee regulatory compliance related to materials (e.g., REACH, RoHS) and collaborate closely with QA and product development teams.
• Manage end of life projections and lead efforts on component replacement strategies.
• Maintain and standardize global parts inventories and develop and deliver training on evolving compliance standards.
• Participate in product development initiatives, ensuring documentation and Design History Files meet FDA QSR and ISO 13485 ISO 9001 standards.
• Conduct internal audits and lead timely, effective corrective action responses.

About You:

• Bachelor's degree in Mechanical, Electrical, BioMedical or Software Engineering (preferred)
• 10 years of experience in complex medical device engineering
• 8 years in a regulated medical device environment
• Deep knowledge of FDA Quality System Regulation (21 CFR Part 820) and ISO 13485
• Experience with medical optics, electronics or reusable medical devices is a PLUS
• Bonus: Ability to evaluate electronic component data sheets in circuit design

Why This Role Matters:

You won't just be checking boxes—you'll be shaping the future of technology in healthcare by driving compliance excellence and product integrity across a global organization. Your work ensures that critical devices meet the highest standards of safety, performance, and innovation.