Overview

Our Fortune 500 medical device client is seeking a Sr. Principal R&D Engineer to lead the development and execution of a robust technology and product pipeline strategy. This role partners with cross-functional leaders to identify, prioritize, and advance high-impact opportunities—overseeing both organic and inorganic innovation initiatives by translating business strategies into product concepts, defining specifications, guiding conceptual design, and validating preliminary business cases to exceed customer and business expectations. They will evaluate trade-offs in cost, time, and risk to make sound, long-term decisions, applying deep expertise in medical device design control to guide projects through all stages of the product development lifecycle. Serving as a core team member at any stage, this individual will articulate a clear vision across the organization, mentor engineers, and provide direction to Engineering Technicians on best practices. Additionally, they will collaborate closely with Marketing to align new product development opportunities with business strategy and deploy innovative resources to research and advance these initiatives.

Responsibilities

• Provide expertise and guidance to Engineering, Marketing, Manufacturing, and Management leaders on exploratory, discovery, TRP, and TDP projects.
• Lead product design and development from concept through production.
• Develop engineering solutions, evaluate competing technologies, research the patent landscape, and file invention disclosures.
• Plan, schedule, and execute assigned projects, ensuring alignment with timelines and deliverables.
• Partner with Sales, Marketing, and clinicians to define requirements for new or modified products.
• Manage and support vendors involved in product development and production.
• Prepare and consult on technical brochures, training programs, and presentations for customers and sales teams.
• Conduct testing, gather product data, and support value analysis initiatives with a focus on design for manufacturability, ergonomics, and cost optimization (COGS).
• Develop product verification/validation requirements, protocols, and reports.
• Provide consultation to other departments, customers, and upstream marketing as needed.
• Troubleshoot and resolve critical product/process issues.
• Perform design analyses (tolerance stack-ups, strength of materials, FEA, risk analysis).
• Maintain strong working knowledge of FDA 21 CFR 820, ISO 14971, IEC 60601, GMP, and related standards.

Qualifications

• Bachelor’s degree in Engineering or equivalent industry experience.
• 10+ years in medical devices with proven ability to engage customers, translate needs into innovative concepts, and make high-level strategic product decisions that shape product direction and market positioning.
• Proficient in creating and critically reviewing engineering drawings and specifications.
• Proficient in Geometric dimensioning and tolerance.
• Strong working knowledge of FDA requirements, including 21 CFR 820, ISO 14971, IEC 60601, GMP and other standards as they relate to the design and manufacture of medical devices.
• Skilled in Microsoft Office, MS Project, and 3D CAD/CAM software.
• Strong problem-solving skills with the ability to guide other engineers.
• Effective collaborator across all levels, functions, and sites.
• Demonstrated ability to manage resources, projects, and timelines to drive results.
• Excellent verbal, written, and presentation skills with the ability to influence stakeholders.
• Seniority level: Mid-Senior level

Nice to have

• Experience in statistical analysis package (Stat Ease, Minitab)

Travel & Location

• Hybrid; flexibility to be on-site for team meetings.
• Westborough, MA
• Brooklyn Park, MN or Centervally, PA acceptable if willing to travel to MA location

Start & Term

Full-time or Contract-to-hire engagement

Benefits

• Medical insurance
• Vision insurance
• 401(k)

Job function

• Engineering and Strategy/Planning

Industries

• Medical Equipment Manufacturing