Medical Device Sr. R&D Engineer | Mechanical

Penumbra, Inc.; San Francisco (CA); On-site; USD 130,000 - 193,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

AD&D Insurance

Disability Insurance

401k with match

Parental Leave

Paid Holidays

Vacation Time

Sick Time

Job summary

Penumbra, Inc. in Alameda, CA is seeking a Senior R&D Engineer to lead the design and development of next-generation medical devices from concept through commercialization.

You will prototype, test, document, and mentor engineers, collaborating with multidisciplinary teams while adhering to Penumbra’s Quality Management System and regulatory requirements. This role emphasizes independent judgment and technical depth.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical, or related discipline preferred).
• 5+ years of experience in R&D Engineering or Product Development within the medical device industry.
• Experience solving hands-on and multi-disciplinary technical design problems.
• Portfolio demonstrating strong engineering acumen and mechanical intuition.
• Refined soft skills that allow you to lead up and lead down with or without a formal reporting structure.
• The ability to communicate complex issues in writing and orally.

Responsibilities

• Design, prototype, and develop new medical devices and components.
• Manage projects as a project leader within a multidisciplinary project team.
• Create comprehensive documentation packages with CAD drawings, product specs, risk analyses, test protocols/reports, studies, and instructions.
• Document R&D process through lab notebooks, engineering protocols, and reports.
• Execute testing and document, interpret, and communicate test results.
• Identify, vet, and utilize vendors in product development.
• Train engineers, technicians and assemblers in new processes and methods.
• Evaluate prototypes against standards or specifications and troubleshoot root causes.

Skills

Engineering acumen

Mechanical intuition

Leadership

Strong communication

Education

Bachelor's degree in Engineering

Advanced degree (preferred)

Job description

As a Senior R&D Engineer, you will be charged with designing game-changing medical devices to address some of the world’s toughest disease states. You will apply creative problem-solving at all stages of the design process, from concept to commercialization, as you provide technical leadership in the design and development of new devices as well as changes to existing devices, processes, and equipment. This role requires strong independent judgment, technical depth, and the ability to conceptualize, develop, specify, test, and implement new designs.

Specific Duties and Responsibilities

• Design, prototype, and develop new medical devices and components.
• Manage projects as a project leader within a multidisciplinary project team.
• Create comprehensive documentation packages that contain CAD drawings, product specifications, risk analysis, test protocols, test reports, studies, work instructions, etc.
• Document research and development process through lab notebooks, engineering protocols, and engineering reports.
• Execute testing and document, interpret, and communicate test results.
• Identify, vet, and utilize vendors in the development of Penumbra products.
• Perform research and integrate new technologies into existing and future products.
• Train engineers, technicians and assemblers in new processes and methods.
• Evaluate prototypes against standards or specifications and troubleshoot problems to assess root cause and corrective action.
• Adhere to Penumbra’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to Penumbra.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.

Position Qualifications

Minimum education and experience:

• Bachelor's degree in Engineering (Mechanical, Biomedical, or related discipline preferred).
• 5+ years of experience in R&D Engineering or Product Development within the medical device industry.
• Experience solving hands‑on and multi‑disciplinary technical design problems.
• A portfolio demonstrating strong engineering acumen and mechanical intuition.
• Refined soft skills that allow you to lead up and lead down with or without a formal reporting structure.
• The ability to communicate complex issues in a clear and compelling manner, both in writing and orally.

Preferred Qualifications

• Advanced degree in Engineering (Mechanical, Biomedical, or related discipline) a plus.
• Experience with endovascular, electromechanical, and/or implantable devices.

Location and Salary:

• Annual Base Salary Range: $130,000 to $193,000
• Location: Alameda, CA
• We offer a competitive compensation package plus a benefits and equity program, when applicable.
• Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Working Conditions

• General office, laboratory, and clean room environments.
• Willingness and ability to work on site.
• Potential exposure to blood-borne pathogens
• Requires some lifting and moving of up to 25 pounds
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to move within the office and access file cabinets or supplies, as needed.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

What We Offer

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra’s commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.