R&D Manager u2013 Product Engineering (Capital ...

Job Description R&D Manager u2013 Product Engineering (Capital Sustaining) Location: Marlborough / Greater Boston Area Work Model: Onsite u2013 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 u2013 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 Postu2011Market 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 decisionu2011making. 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 u2003u2022 Lead sustaining engineering activities for a portfolio of capital medical devices, balancing technical, regulatory, and business priorities. u2003u2022 Own and guide endu2011ofu2011life (EOL) strategies, including component obsolescence, product replacement planning, reu2011testing, rationalization, and nextu2011generation replacement efforts. u2003u2022 Drive decisionu2011making around when to remediate, redesign, replace, or retire products, ensuring patient safety, compliance, and continuity. u2003u2022 Act as a u201cplayeru2011coachu201d, stepping in as needed to fill technical or execution gaps and keep initiatives moving forward. Remediation, Quality & Compliance u2003u2022 Partner closely with Quality and Design Assurance to lead and execute remediation programs across legacy products and multiple business units. u2003u2022 Improve the overall approach to quality and compliance, driving visibility, structure, and accountability across the legacy portfolio. u2003u2022 Ensure products and engineering activities remain aligned with internal QMS, FDA Design Controls, Risk Management requirements, and ISO 13485 standards. u2003u2022 Support and lead CAPAu2011driven remediation efforts, working handsu2011on with quality partners to define and execute corrective actions. u2003u2022 Provide a strong engineering perspective when working with quality teamsu2014constructively pushing back where needed to ensure remediation plans are technically sound, risku2011based, and pragmatic. u2003u2022 Maintain awareness of compliance considerations such as EMI/EMC and applicable regulatory testing requirements. Crossu2011Functional & Manufacturing Collaboration u2003u2022 Work closely and daily with Manufacturing teams, lifecycle management partners, and postu2011market colleagues to resolve field issues, manufacturing challenges, and customeru2011reported defects. u2003u2022 Triage incoming demands from multiple stakeholders, helping prioritize work that delivers the greatest impact and makes the most technical and business sense. u2003u2022 Serve as a primary interface between Engineering, Manufacturing, Quality, Design Assurance, and Postu2011Market teams, clearly communicating tradeoffs and priorities. Team Leadership & Vision u2003u2022 Lead and develop a small but critical team of engineers, currently consisting of 2 Lead Engineers, with plans to grow. u2003u2022 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. u2003u2022 Balance people development and technical credibilityu2014this role values both strong leadership acumen and deep engineering experience. u2003u2022 Manage performance, provide coaching and feedback, and support professional growth. u2003u2022 Bring prior people management experience, while remaining comfortable working within a lean team environment. Program & Execution Management u2003u2022 Apply strong program management discipline to manage multiple parallel initiatives across remediation, sustaining engineering, and lifecycle updates. u2003u2022 Allocate resources effectively across Lifecycle Management, Quality, and Compliance initiatives. u2003u2022 Communicate clearly and effectively with both technical and nonu2011technical stakeholders through documentation, presentations, and regular updates. u2003u2022 Advocate for and manage the teamu2019s 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 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 u2003u2022 Bacheloru2019s or Masteru2019s degree in Electrical, Mechanical, Biomedical Engineering, or related discipline. u2003u2022 8+ years of experience in the medical device industry, with handsu2011on exposure to Design Controls, Risk Management, and sustaining engineering. u2003u2022 Experience supporting Class II medical devices; prior surgical experience is not requiredu2014device classification and complexity matter more than domain. u2003u2022 Demonstrated experience managing engineers and leading crossu2011functional initiatives. u2003u2022 Background supporting complex electrou2011mechanical or capital equipment strongly preferred. Skills & Attributes u2003u2022 Strong working knowledge of Design Controls, Product Lifecycle Management, and Risk Management. u2003u2022 Solid compliance foundation; experience with ISO 13485, EMI/EMC, and regulated testing environments is a plus. u2003u2022 Comfortable operating in a fastu2011paced, stakeholderu2011heavy environment with competing priorities. u2003u2022 Excellent communication skills and ability to influence within a matrixed organization. u2003u2022 Strong technical judgment and troubleshooting skills across hardware, systems, and manufacturing interfaces. u2003u2022 Ability to balance two ends of the equation: u2003u2003u25cb Deep technical competence and experience, and u2003u2003u25cb Strong communication, leadership, and people development skills

Created: 2026-04-15