Principal Engineer - Human Centered Design

Member of the R&D department at Sage Products, a business unit within Stryker. This Individual drives user-centered product development across medical devices and integrated ecosystems. This role blends human factors engineering, UX research, clinical workflow analysis, procedure mapping, interaction design, and usability testing to ensure devices are intuitive, safe, and aligned to real clinical needs. They will work within R&D to partner with upstream marketing, clinical/medical affairs, systems engineering (where necessary), and design teams to translate insights into clear system and user requirements.

Know more about line of Business here: Sage Products

What you will do:

• Lead ethnographic research, contextual inquiries, and OR/ICU observations to synthesize VOC, create journey maps, workflows, and procedure maps, and identify unmet needs translated into actionable product requirements in partnership with Marketing and R&D.
• Drive human factors engineering activities, including formative usability studies and support of summative validation; develop user profiles, task analyses, use specifications, and use‑related risk analyses (URRA/UFMEA) across multiple programs.
• Provide expert guidance on HFE strategy, review and approve HFE documentation, and partner with Regulatory to ensure compliance with IEC 62366‑1 and FDA Human Factors guidelines.
• Translate user needs into clear requirements, interaction guidelines, and design principles, partnering across UX/UI, Industrial Design, Systems Engineering, and R&D to create safe, intuitive workflows.
• Support low‑ to high‑fidelity prototyping and simulation evaluations, influencing early‑stage concept development, pipeline creation, and identification of strategic opportunity areas.
• Serve as the human‑centered design leader across multiple programs, defining portfolio‑ and platform‑level design strategy while facilitating cross‑functional workshops, design sprints, and collaborative concepting sessions.
• Mentor and coach engineers and designers on research methods, synthesis, human‑factors regulatory pathways, and design strategy; partner with upstream marketing to shape problem spaces and future program need statements.
• Own key Human Factors Engineering deliverables, including HFE plans, research protocols, usability reports, and traceability matrices, while contributing to Design History File (DHF) inputs and risk management documentation.

What you will need:

Required (minimum) Qualifications:

• Bachelor’s degree in Human Factors, Engineering, Cognitive Science, Product Design, HCI, or related field.
• 8+ years relevant experience
• Expertise in human factors methods, qualitative research, usability testing, and requirements definition.
• Excellent communication skills with proven ability to influence cross-functional teams.

Preferred Qualifications:

• Master's degree in Human Factors, Biomedical Engineering, Cognitive Science, Product Design, HCI, or related field.
• Membership in a related trade or technical organization (HFES, etc.)
• 10+ years of related work experience in medical devices or other regulated industries.
• Familiarity with IEC 62366 1, ISO 14971, and FDA HFE guidance.

$118,000- $255,700 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.