Principal R&D Engineer
Company: Silk Road Medical Inc
Location: Sunnyvale
Posted on: May 16, 2022
Job Description:
Job Description Summary: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.Requirements:
- 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.
Keywords: Silk Road Medical Inc, Sunnyvale , Principal R&D Engineer, Engineering , Sunnyvale, California
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