ClariMed is a human-centered development and regulatory practice for medical products developed by Pharmaceutical and Medical device manufacturers. Our best-of-breed professional services cultivate innovation while ensuring the safe and effective use of medical products.
Operating out of Chadds Ford, PA with offices in San Jose, Boston, and Cambridge, UK, ClariMed is building a global, boutique professional services practice that provides human centered design, development and regulatory services to medical device and pharmaceutical manufacturers. With a grounding in quality by design, creativity and risk mitigation from concept inception through pilot lot delivery, we intend to reduce time to market, enhance product quality and convey a compelling risk/benefit positioning for our clients. We will achieve this by intentionally coupling the flexibility of a boutique offering with the breadth of services of a global business, while avoiding the conflicts that come with manufacturing and clinical operations. Visit us at www.ClariMed.com.
About the Role
As a Human Factors Engineer at ClariMed, you will support human factors activities across the medical device product development lifecycle. You’ll work closely with senior team members and clients to conduct user research, support usability testing, and contribute to the development of human factors documentation for regulatory submissions.
This role is ideal for someone who enjoys hands‑on research, problem solving, and collaborating with multidisciplinary teams to design products that improve patient and clinician outcomes.
What You’ll Do
Support Human Factors Research & Analysis
- Conduct task analyses, user research, and contextual inquiries.
- Assist with development and maintenance of usability risk analyses (e.g., URAs, UFMEAs).
- Help identify user needs, use‑related hazards, and potential risk mitigations.
Assist with Usability Testing
- Contribute to development of formative and summative usability study protocols.
- Support planning and coordination of usability studies, including scenario development and study logistics.
- Observe or moderate usability testing sessions with healthcare professionals and lay users.
- Assist with analysis of qualitative and quantitative usability data.
Contribute to Human Factors Documentation
- Assist with preparation of usability study reports and HF deliverables.
- Support development of Human Factors Engineering (HFE) documentation aligned with FDA guidance, IEC 62366, and applicable standards.
- Ensure deliverables meet ClariMed’s quality system requirements.
Collaborate with Project Teams
- Work with human factors engineers, designers, and project managers to support usability‑driven design recommendations.
- Participate in project meetings and client discussions.
- Support project timelines, deliverables, and documentation.
What We’re Looking For
Required Skills & Experience
- Knowledge of human factors principles and usability engineering methods.
- Familiarity with medical device development and usability testing.
- Strong analytical, communication, and technical writing skills.
- Ability to synthesize research findings into clear insights and recommendations.
- Experience interacting with users, including healthcare professionals or lay users.
- Proficiency with Microsoft Office Suite.
Education & Experience
- M.A./M.S. in Human Factors Engineering, Biomedical Engineering, or related field preferred.
- B.A./B.S. in a related field (Human Factors, Engineering, Psychology, Cognitive Science, Industrial Design) also accepted.
- 1–4 years of experience in human factors, usability research, medical devices, or a related field (or equivalent combination of experience and education).
Why Join ClariMed?
- Work on cutting‑edge medical device technologies that have real‑world impact.
- Collaborative, people‑focused culture with opportunities for growth.
- Exposure to a wide variety of products, clients, and project types.
- Opportunities to learn from experienced human factors professionals.
- Competitive compensation and benefits package.
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