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Senior R&D Engineer (Andover, MA)

Smith & Nephew
$106,500 - $159,500
parental leave, paid holidays, tuition reimbursement, 401(k), stock options
United States, Massachusetts, Andover
150 Minuteman Road (Show on map)
Feb 20, 2026

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 endtoend 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 stagegate 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 stagegate 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 phasegate reviews with wellstructured technical documentation and data.

-CrossFunctional 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

- Mentor junior engineers and scientists, providing technical guidance and development support.

- Serve as a technical subject matter expert for assigned products or technology areas.

- Promote best practices in product development, documentation, and crossfunctional collaboration.

What will you need to be successful?

  • Bachelor's Degree in scientific or engineering discipline with 5+ years' experience of relevant industry experience is required.

  • Master's or PhD degree in scientific or engineering discipline with experience of relevant industry experience is preferred.

  • Minimum 5 years of relevant experience with demonstrated ability to manage projects from concept to commercialization in medical device, pharmaceutical/biotechnology industry.

  • Excellent communication skills and interpersonal/team effectiveness, ability to communicate to various levels of management.

  • Proven ability to deliver results in a matrix organization and effectively collaborate with leadership.

  • Demonstrated experience leading medical device product development through the full design control lifecycle, with specific experience in bioengineered collagen, extracellular matrix (ECM), or tissue-based products.

Work Environment

  • General biochemical/mechanical/chemical lab equipment/Frequently

Physical Demands

  • Must be able to stand and/or sit for extended periods of time

    Must be able to push, pull, squat, bend, and reach above shoulders

    Repetitive use of hands

    Ability to view computer screen for extended periods

    Must be able to lift and carry objects up to 20lbs

    May need to use common hand and power tools

  • Travel requirements: 25%

You Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.

  • Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website ( https://www.smith-nephew.com/).

  • Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement

  • Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day

  • Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

  • Flexibility: Hybrid Work Model (For most professional roles)

  • Training: Hands-On, Team-Customized, Mentorship

  • Extra Perks: Discounts on fitness clubs, travel and more!

#LI-HYBRID

"The anticipated base compensation range for this position is $106,500 - $159,500 USD annually.

The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate.

In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings. "

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.

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