R&D Manager - Product Engineering (Medical Devices)

R&D Manager – Product Engineering (Capital Sustaining)

Location: Marlborough / Greater Boston Area

Work Model: Onsite – 5 days per week (there ultimately will be flexibility but they want it prefaced as onsite)

Division: R&D

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

About the Role

Join our clients' Surgical Division as an R&D Manager – Product Engineering and play a critical role in sustaining and evolving our capital medical device portfolio. This role is responsible for ensuring product reliability, regulatory compliance, and long‑term lifecycle viability across complex Class II medical devices.

This is a highly hands‑on, onsite leadership role requiring close, daily collaboration with Manufacturing, Design Assurance, Quality, Lifecycle Management, and Post‑Market teams. The role is well‑suited for a leader who thrives in ambiguity, can triage competing demands, and is comfortable stepping in to fill gaps where needed to keep work moving forward.

A significant portion of this role will focus on legacy portfolio visibility, remediation, and lifecycle decision‑making, helping elevate Hologic’s overall approach to quality and compliance across business units.

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.

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