Sr. R&D Engineer

General Summary

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.

 

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.