R&D Manager - Product Engineering (Capital Sustaining)

Job Description

R&D Manager - Product Engineering (Capital Sustaining)

Location: Marlborough / Greater Boston Area

Work Model: Onsite - 5 days per week (flexibility expected over time, but the role should be positioned as onsite)

Division: Research & Development

Team Size: 3 engineers currently (including 2 Lead Engineers, with planned growth)

About the Role

A leading medical device organization is seeking an R&D Manager - Product Engineering to support the sustaining and evolution of a complex capital equipment portfolio. This role is accountable for ensuring product reliability, regulatory compliance, and long-term lifecycle viability across Class II medical devices.

This is a highly hands-on, onsite leadership position that requires close, day-to-day collaboration with Manufacturing, Design Assurance, Quality, Lifecycle Management, and Post-Market teams. The ideal candidate is comfortable operating in ambiguity, can effectively triage competing priorities, and is willing to step in where needed to keep critical workstreams moving forward.

A significant focus of this role will be on legacy portfolio visibility, remediation efforts, and lifecycle decision-making. The manager will play a key role in strengthening overall quality, compliance, and sustaining engineering practices across the broader organization.

Key Responsibilities

Product Sustaining & Lifecycle Management

• Lead sustaining engineering activities for a portfolio of capital medical devices, balancing technical, regulatory, and business priorities.

• Own and guide end-of-life (EOL) strategies, including component obsolescence, product replacement planning, re-testing, rationalization, and next-generation replacement efforts.

• Drive decision-making around when to remediate, redesign, replace, or retire products, ensuring patient safety, compliance, and continuity.

• Act as a "player-coach", stepping in as needed to fill technical or execution gaps and keep initiatives moving forward.

Remediation, Quality & Compliance

• Partner closely with Quality and Design Assurance to lead and execute remediation programs across legacy products and multiple business units.

• Improve the overall approach to quality and compliance, driving visibility, structure, and accountability across the legacy portfolio.

• Ensure products and engineering activities remain aligned with internal QMS, FDA Design Controls, Risk Management requirements, and ISO 13485 standards.

• Support and lead CAPA-driven remediation efforts, working hands-on with quality partners to define and execute corrective actions.

• Provide a strong engineering perspective when working with quality teams-constructively pushing back where needed to ensure remediation plans are technically sound, risk-based, and pragmatic.

• Maintain awareness of compliance considerations such as EMI/EMC and applicable regulatory testing requirements.

Cross-Functional & Manufacturing Collaboration

• Work closely and daily with Manufacturing teams, lifecycle management partners, and post-market colleagues to resolve field issues, manufacturing challenges, and customer-reported defects.

• Triage incoming demands from multiple stakeholders, helping prioritize work that delivers the greatest impact and makes the most technical and business sense.

• Serve as a primary interface between Engineering, Manufacturing, Quality, Design Assurance, and Post-Market teams, clearly communicating tradeoffs and priorities.

Team Leadership & Vision

• Lead and develop a small but critical team of engineers, currently consisting of 2 Lead Engineers, with plans to grow.

• Establish a clear vision for a new and evolving team, including how the group should scale, where capabilities need to expand, and what success looks like.

• Balance people development and technical credibility-this role values both strong leadership acumen and deep engineering experience.

• Manage performance, provide coaching and feedback, and support professional growth.

• Bring prior people management experience, while remaining comfortable working within a lean team environment.

Program & Execution Management

• Apply strong program management discipline to manage multiple parallel initiatives across remediation, sustaining engineering, and lifecycle updates.

• Allocate resources effectively across Lifecycle Management, Quality, and Compliance initiatives.

• Communicate clearly and effectively with both technical and non-technical stakeholders through documentation, presentations, and regular updates.

• Advocate for and manage the team's budget and resourcing needs.

Compensation: $122,000 to $190,000. Exact compensation may vary based on several factors, including skills, experience, and education.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

Qualifications & Experience

• Bachelor's or Master's degree in Electrical, Mechanical, Biomedical Engineering, or related discipline.

• 8+ years of experience in the medical device industry, with hands-on exposure to Design Controls, Risk Management, and sustaining engineering.

• Experience supporting Class II medical devices; prior surgical experience is not required-device classification and complexity matter more than domain.

• Demonstrated experience managing engineers and leading cross-functional initiatives.

• Background supporting complex electro-mechanical or capital equipment strongly preferred.

Skills & Attributes

• Strong working knowledge of Design Controls, Product Lifecycle Management, and Risk Management.

• Solid compliance foundation; experience with ISO 13485, EMI/EMC, and regulated testing environments is a plus.

• Comfortable operating in a fast-paced, stakeholder-heavy environment with competing priorities.

• Excellent communication skills and ability to influence within a matrixed organization.

• Strong technical judgment and troubleshooting skills across hardware, systems, and manufacturing interfaces.

• Ability to balance two ends of the equation:

? Deep technical competence and experience, and

? Strong communication, leadership, and people development skills