Principal Medical Device R&D Engineer - Lead & Deliver

EPM Scientific; San Francisco (CA); On-site; USD 140,000 - 220,000; Full time

Job summary

EPM Scientific is seeking a Principal R&D Engineer to lead development, verification, validation, and commercialization of Class II/III medical devices in a regulated environment. You will drive design transfer, risk management, and design controls while partnering with Quality, Regulatory, Clinical, Marketing, and Manufacturing to deliver patient-impacting innovations.

The role emphasizes technical leadership across disciplines, robust documentation, and collaboration with external partners to

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Electrical, Chemical engineering, or related field.
• 10+ years of medical device product development experience.
• Experience leading complex product development programs in regulated medical devices.
• Strong knowledge of Design Controls and product development processes.
• Experience with ISO 14971 and FMEA risk management methodologies.
• Proven experience authoring and reviewing verification and validation protocols/reports.
• Experience supporting regulatory submissions and compliance activities.
• Strong analytical, problem-solving, and technical leadership skills.
• Experience in FDA-regulated and ISO 13485 environments.
• Excellent communication and cross-functional leadership capabilities.

Responsibilities

• Lead technical development of new medical device products from concept through commercialization.
• Serve as technical lead for complex, high-visibility projects.
• Develop product requirements, design inputs, specifications, and documentation.
• Drive risk management activities including hazard analyses and risk assessments.
• Design and execute verification and validation strategies and reports.
• Support human factors, usability engineering, and design validation.
• Lead root cause investigations and design improvements.
• Apply Design Controls per FDA 21 CFR Part 820, ISO 13485, and standards.
• Collaborate with manufacturing during process development and transfer.
• Drive manufacturability improvements using DFM and DFA principles.
• Interface with suppliers and external partners for component development.
• Support regulatory submissions, technical files, and audits readiness.
• Analyze data and apply statistical methods to engineering decisions.
• Mentor engineers and present updates to senior leadership.
• Lead technical reviews and project updates to leadership.

Skills

Analytical skills

Problem solving

Technical leadership

Cross-functional leadership

Communication

Regulatory knowledge

Education

Bachelor's degree in engineering

Tools

FMEA

DOE

Statistical analysis

Job description

EPM Scientific is seeking a Principal R&D Engineer to lead development, verification, validation, and commercialization of Class II/III medical devices in a regulated environment. You will drive design transfer, risk management, and design controls while partnering with Quality, Regulatory, Clinical, Marketing, and Manufacturing to deliver patient-impacting innovations.

The role emphasizes technical leadership across disciplines, robust documentation, and collaboration with external partners to