Senior R&D Engineer (Andover, MA)

Smith+Nephew•Andover, MA

1d•Hybrid

About The Position

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 - 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 cross‑functional 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. Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart. Through a spirit of ownership and can-do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.

Requirements

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

Nice To Haves

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

Responsibilities

Lead and execute product development activities across all lifecycle phases
Own and manage stage‑gate deliverables
Translate user needs and clinical requirements into clear, testable design inputs and engineering solutions.
Ensure product designs meet performance, safety, manufacturability, and regulatory requirements.
Serve as a key contributor and owner of design control activities
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.
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.
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.
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.
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 cross‑functional collaboration.