Senior Human Factors Engineer (Andover, MA)

Senior Human Factors Engineer (Andover, MA)

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

Smith + Nephew supports healthcare professionals in more than 100 countries in their daily efforts to improve the lives of their patients. We do this by taking a pioneering approach to the design of our advanced medical products and services , by securing wider access to our diverse technologies for more customers globally, and by enabling better outcomes for patients and healthcare systems.

We have leadership positions in:

We have around 15,000 employees around the world. Annual sales in 2018 were more than $4.7 billion . We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NY).

What will you be doing?

As a Senior Human Factors Engineer on the Smith+Nephew Human Factors+Design team, you will lead user research and usability engineering activities for innovative devices used by clinicians and patients worldwide. This role combines deep regulatory expertise with hands-on‑ design influence, shaping product strategy from early discovery through regulatory submission and launch.

As the owner of HF strategy for assigned programs, you will support the delivery of projects by informing design through user research, reviewing HF literature, iteratively testing concepts, leading external partners and compiling reports for submission to regulatory authorities. You will also make independent recommendations to cross-functional leadership and serve as the HF subject matter expert during regulatory interactions.

With a primary focus in Sports Medicine and ENT programs, you will lead research across multiple programs to understand users (clinicians and lay users), use environments, user characteristics, behaviors and constraints.

You will lead formative and summative usability studies, ethnographic research (e.g., OR observations, in-home‑ use evaluations), task analyses, contextual inquiries, and iterative concept evaluations to inform both product design and business strategy.

You will demonstrate and champion user-centered design principals, employ design thinking activities, identify unmet needs and generate design requirements while ensuring human factors and usability regulatory requirements are met . For existing products where changes to the user interface are proposed you will provide an ongoing assessment, identifying any additional work required.

You will develop and maintain an understanding of the latest information regarding Usability and Human Factors testing for medical devices.

You will ensure all activities are performed and maintained in the QMS in accordance with relevant national and international standards.

You will place special emphasis on IEC62366 – 1, the FDA’s guidance Applying Human Factors and Usability Engineering to Medical Devices, and the NMPA Guidelines for the review of medical device usability engineering registration.

You will maintain a network of external contacts who can be referred to for advice when appropriate.

Travel Up (international and domestic) up to 25%

What will you need to be successful?

• Bachelor's Degree in relevant area (Human Factors, Industrial Design, Cognitive Psychology, Engineering)

• Preferred: Human Factors/Ergonomics MS, PhD, or certification

• 5-8 years’ experience in product development with the application of Human Factors Engineering to product/system design, preferred in a regulated industry

• Project and third party management experience (budget >$100k)

• Significant working knowledge of Usability/Human Factors Engineering in a medical device environment

• Experience designing, moderating, and reporting on usability studies

• Knowledge and understanding of Human Factors/Usability standards for medical devices and human-centered design principles

• Experience of working on medical devices, capital equipment, software GUI’s

• Experience working closely with design teams

• Strong organizational, prioritization and communication skills

• Proficiency using generative Ai tools for varied applications

Competencies

• You know and care about the business

• You focus on the customer

• You build positive relationships

• You embrace innovation and change management

• You deliver on commitments

• You value people

Other

• Software proficiency: Microsoft Office Suite: Teams, OneDrive, Copilot Word, PowerPoint, Excel, Outlook

• Preferred: Adobe Creative Suite, Jama, Jira, Figma

Internal Supervision

• Opportunity to lead and coach more junior team members

• Build and maintain internal relationships

• This role will predominantly involve communication with other functions at a similar level, functional managers of other departments, and corresponding project managers.

External Relationships

• Your day will include extensive communication with third party authorities.

• You will be able to engage with external human factors and design partners.

• You will take advice regarding overall strategic direction on projects from HF and design Manager, but require little supervision in day-to-day activity.

• We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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 (

• 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!  

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"The anticipated base compensation range for this position is $111,750 - $167,500 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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