The Principal Sustaining Engineering R&D Engineer is responsible for post commercial engineering activities for the Silk Road Medical product portfolio. These engineering activities could be associated with Geography or Indication Expansion, Worldwide Regulatory Requirements, Field Complaint Management, Shelf Life Expansion, second sourcing and ongoing Design Related Manufacturing Support as needed.
Essential job functions:
- Define and complete Post Commercial engineering activities for the Silk Road Medical product portfolio.
- Work collaboratively with Marketing, Clinical, Medical Director, and physician advisors to understand customer requirements. Develop deep understanding of procedural constrains, needs, and customer expertise to better inform ongoing work.
- Work collaboratively with Regulatory, Quality and Manufacturing to define project needs and drive execution of the design related deliverables.
- Develop and lead verification and validation activities, as needed for geography or indication expansions, to ensure that product designs meet the customer needs. This shall include bench testing, model/fixture development, ex vivo and/or in vivo testing as appropriate.
- Perform troubleshooting of issues related to commercial products as related to design, material, or process.
- Support the development and upkeep of the Company's Quality System in conjunction with the Company's Quality Department.
- Work with Marketing and Medical Affairs to develop training tools and models; direct interface with field personnel and customers.
- BS in Biomedical Engineering, Mechanical Engineering, Materials Engineering, or a related discipline; MS degree is a plus.
- 10+ years of experience in industry; minimum 4 years in medical device R&D.
- Previous experience with catheter design and/or manufacturing.
- Previous experience in utilizing and managing outside vendors for design, testing and manufacturing.
- Previous experience with implantable nitinol devices is a plus.
- Product Development Process (PDP) experience for Medical Devices. Specifically, Design Control, Design Verification & Validation, Test Method Validation.
- Excellent hands-on design and prototyping skills.
- Highly organized, energetic, self-starter who exhibits strong communication skills with cross-functional team members, project leads, and physician advisors.
- Technical Leadership experience and strong report writing, drafting and documentation skills.
- Proficient with the following: 3D Modeling (SolidWorks), FEA desirable (not required), Microsoft Office Suite.
- Excellent understanding of FDA Regulation and Quality systems requirements for Medical Device Manufacturers.
- Ability to travel up to 20%.
COVID-I9 Vaccine Requirement: It is the policy of Silk Road Medical to require all employees to be vaccinated against the COVID-19 virus. Employees must: (a) establish proof of full vaccination authorized by the U.S. Food & Drug Administration to prevent COVID-19 or (b) obtain an approved exemption from SRM as a medical or religious accommodation.