About Clarimed, Inc.
We are headquartered in Chadds Ford, PA. We are driving to become:
“The premium, human-centered development and regulatory practice for medical products, point of care devices, companion and combination products, and SaMD.”
ClariMed was formed with the vision that a unique market opportunity exists to build the leader in human-centered regulatory and development services for medical products. We believe that a focus on placing human factors at the core of device development and regulatory pathways translates to a “quality by design” approach that drives outsized value for patients, customers, and stakeholders. We also believe that a stronger calibration to risk/benefit is emerging and will continue to be a driver of market clearance and reimbursement, which in turn will lead to clients that place an emphasis on “smarter” development.
Position Summary:
As a full-time Human Factors Engineering Manager at ClariMed, you will empower human factors engineers to consult innovative companies to design safe and usable medical devices, ensuring that user experience is incorporated early and often in the design process. At ClariMed, we pride ourselves on being experts and having experience in a variety of products including wearable sensors, surgical devices, diagnostic equipment, drug administration devices, and home-use devices.
Roles and Responsibilities:
- Managing resource allocation for all ClariMed projects.
- Analyze available resources.
- Matching the background and training of specific consultants with specific projects.
- Having technical discussions with team members to agree on project scope and delivery schedules, tracking schedules and related dependencies.
- Manage more than 5 human factors engineers and interns, including overseeing employee onboarding and training, promoting professional development and mentoring employees, promoting employee engagement and alignment between working goals and personal aspirations, providing regular feedback to facilitate personal growth.
- Manage operations to key delivery metrics including utilization, Net Promoter Score, project budget adherence, and forecasting.
- Write performance reviews and solve internal issues.
- Assist with establishment of annual goals and ensuring employees have opportunity to meet goals.
- Collaborating on distribution of the bonus pool and determining promotions and merit increases.
- Overseeing hiring (working with the Human Resources department), hire, train, and mentor other engineers and supporting staff, hire and manage contractors.
- As appropriate, review, approve, or modify project work and check technical accuracy of work.
- Driving quality improvement initiatives and engineering processes.
- Promote positive relationships and professional rapport with ClariMed’s clients.
- Provide expert consultations for clients and ClariMed staff, as needed, on applicable guidance, standards, regulations, and regulatory expectations related to Human Factors and Usability Engineering for medical products.
- Attend sales meetings and lead direct reports to prepare proposals.
- Support ClariMed promotion and presence as an industry thought leader (e.g., presenting at conferences, supporting standard development).
- Develop both internal and external trainings.
- In collaboration with other SMEs, perform final review of work product before sending deliverables to clients.
Candidate Requirements:
- M.A./M.S. in Engineering preferred. B.A./B.S. in Engineering also acceptable.
- Experience with resource allocation and tracking, preferably in the engineering services/consulting space.
- At least 5 years of experience in the medical device or similarly regulated industry.
- Exposure to Human Factors Engineering, and experience in a tangential field such as R&D, clinical testing, or user-experience design.
- Strong understanding of medical device product design and regulatory processes.
- Experience working within a quality system, preferably at a Fortune 500 medical device or pharmaceutical company.
- Ability to collect and synthesize large quantities of information across the broader team into usable communications (i.e., protocols, reports, operating procedures).
- Excellent technical problem-solving and interpersonal skills that result in clear verbal communication and presentation skills.
- Experience working with a wide variety of population demographics is desired.
- Ability to work on-site in San Jose, California.