Senior R&D Engineer (Andover, MA)

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.   

The Senior Product Development Engineer is responsible for the end‑to‑end development and execution of medical device and biologics programs, supporting products from concept and feasibility through development, validation, regulatory submission, and launch.

This role serves as a core technical owner of product development activities within the Biologics and Regenerative Medicine (Biologics) enterprise, with a strong focus on design controls, product lifecycle management, and stage‑gate execution. The engineer ensures that all development activities meet quality system, regulatory, and business requirements, while delivering robust, manufacturable products aligned with customer and clinical needs.

The position operates in a highly matrixed environment, collaborating closely with Quality, Regulatory Affairs, Clinical, Manufacturing, Marketing, and external partners to deliver program milestones and portfolio objectives.

What will you be doing?

Product Development & Lifecycle Ownership

- Lead and execute product development activities across all lifecycle phases, including:

o   Concept & early innovation

o   Feasibility & technology assessment

o   Design & development

o   Verification & validation

o   Transfer to manufacturing

o   Launch and sustaining support

- Own and manage stage‑gate deliverables, ensuring readiness, completeness, and alignment with program objectives.

- Translate user needs and clinical requirements into clear, testable design inputs and engineering solutions.

- Ensure product designs meet performance, safety, manufacturability, and regulatory requirements.

- Design Controls & Quality System Execution

- Serve as a key contributor and owner of design control activities, including:

o   Design History File (DHF) creation and maintenance

o   User needs, design inputs, outputs, and traceability

o   Risk management (e.g., hazard analysis, FMEA)

o   Design verification and validation (V&V)

- Ensure compliance with applicable quality system requirements and internal procedures throughout the product lifecycle.

- Support design reviews and phase‑gate reviews with well‑structured technical documentation and data.

- Cross‑Functional Execution & Program Delivery

- Partner with Quality, Regulatory Affairs, Clinical, Manufacturing, and Marketing to ensure alignment across development, regulatory strategy, and launch readiness.

- Support regulatory submissions (e.g., 510(k), technical documentation) through generation and review of technical content.

·        Coordinate and execute development activities to meet program timelines, cost targets, and performance goals.

- Guide stakeholders in understanding technical tradeoffs and applying data to make informed decisions.

- External Partner & Vendor Management

- Act as a technical point of contact for external vendors, CROs, and suppliers, providing oversight of development, testing, and validation activities.

- Ensure consistent practices, quality, and documentation across external partners.

- Troubleshoot technical issues and manage risks associated with outsourced development activities.

- Engineering, Prototyping & Technical Execution

- Support or lead prototyping, test method development, and evaluation activities.

- Utilize engineering tools and techniques, including:

o   3D modeling and engineering drawings

o   GD&T, inspection methods, and test protocols

o   Data analysis and design iteration

- Contribute to product claims, intellectual property, and technology assessments as appropriate.

- Mentorship & Technical Leadership

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