Principal Human Factors Engineer (Plymouth)

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies.

The Renal Human Factors team is a part of the R&D organization that supports the Renal Care business unit. Within the team, we provide Human Factors activities in all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems. This collaborative role gives you the direct opportunity to define solutions to new products and services to patients and continue Vantive's mission to save and sustain lives.

In this role as a Human Factors Engineer, you will directly influence the usability and the patients/user's perception of the Vantive products. You will apply human factors engineering principles to the design, development, and evaluation of medical products while working with cross-functional program teams.

What you will be doing:

• Lead human factors engineering work and research for medical devices and regulated healthcare products.
• Perform human factors/usability studies (formative and summative) for hardware, software, labeling, and disposable products.
• Design and execute usability evaluations to secure safe and easy product use.
• Lead the development of a Use-Related Risk Analysis, as part of the risk file for the products.
• Develop and communicate Human Factors project scope, plans, tasks and deliverables with program teams; manage time to meet project deadlines.
• In partnership with other R&D teams, develop product prototypes for user interface evaluation and validation.
• With minimal direction, direct and coordinate all human factors activities necessary to complete a major product development program or several small projects.
• Lead efforts to develop processes and procedures that align to Vantive initiatives and FDA/international human factors standards.
• Provide technical supervision to less experienced human factors engineers and may be responsible for the management of a small work group.
• Present and advise on human factors topics across the organization.

What you will bring:

• Masters degree in Human Factors Engineering or equivalent.
• 7+ years of human factors relevant experience; experience in medical device industry preferred.
• Proven experience in HFE principles and methodologies (ergonomics, usability evaluations, data collection, data analysis, etc.).
• Proven experience in applying human factors techniques on programs across product lifecycle (user research, prototyping, formative & summative product evaluation, use-related risk analysis, etc.).
• Demonstrated working knowledge of IEC 60601-1-6, IEC 62366, and FDA HF/Usability Guidance Document and experience working in regulated industry.
• Strong interpersonal and communication skills in written and verbal form.
• Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (Marketing, Quality, Regulatory, etc.).
• Demonstrated ability to provide technical leadership for HFE projects with substantial complexity and scope.
• Ability to decompose complex problems into actionable task lists.
• Understanding of design requirements for development, validation, and verification of medical products.

Vantive is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000 - 130,000 annually. Individual pay is based upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

US Benefits at Vantive:

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan (Aon PEP), Vantive's 401(k) retirement savings plan, to help you prepare for your future.

We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

Join us and enjoy the competitive compensation and benefits we offer to our employees.

Equal Employment Opportunity:

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodation:

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information.