Sr. R&D Engineer, Systems
Company: Shockwave Medical, Inc.
Location: Santa Clara
Posted on: September 20, 2024
Job Description:
Shockwave Medical, Inc. is a pioneer in the development and
commercialization of Intravascular Lithotripsy (IVL) to treat
complex calcified cardiovascular disease. Shockwave Medical aims to
establish a new standard of care for medical device treatment of
atherosclerotic cardiovascular disease through its differentiated
and proprietary local delivery of sonic pressure waves for the
treatment of calcified plaque.DescriptionPosition OverviewThe Sr.
R&D Engineer, Systems will work with cross-functional teams to
develop and sustain products at Shockwave Medical that satisfy
customer needs and drive business strategies. The Sr. R&D
Engineer, Systems will engage in specification writing and
development; test and report writing and development; execute
testing; DHF maintenance; and provide support to other departments
as required.Essential Job Functions
- Design and develop product(s) and documentation in full
compliance with the company's Design Control requirements and
consistent with FDA, ISO, and MDD criteria.
- Participate on cross-functional development teams that manage
projects from concept through commercialization.
- Evaluate existing document architecture and assess for gaps and
dependencies.
- Work with stakeholders to establish project needs and
functional group interfaces.
- Work with on-market groups and data sets to assess device
performance.
- Support sustaining activities for on-market products.
- Support quality audits and follow-up activities.
- Ensure lab notebooks are documented in a timely manner and
consistent with the applicable SOP.
- Develop protocols/reports and perform product in-vitro, in-vivo
verification and validation testing.
- Good written and verbal communication skills to convey complex
concepts and approaches. Provide support to operations and
regulatory initiatives as required.
- Other duties as needed.Requirements
- Bachelor's degree in Biomedical Engineering, Mechanical
Engineering, or Electrical Engineering with 5+ years of medical
device experience, or a Master's degree in Biomedical Engineering,
Mechanical Engineering, or Electrical Engineering with 3+ years of
medical device experience.
- Familiarity with Design History Files (DHF), Design Master
Records (DMR), Traceability Matrices, and other outputs of the
Product Development Process.
- Familiarity with risk management processes and applications
including FMEA, FTA and general risk analysis.
- Strong working knowledge of 820.30 and the medical device
development process.
- Working knowledge of GDP (Good Documentation Practices) and an
ISO 13485 regulated environment.
- Experience with JAMA is a plus.
- Ability to work in a fast-paced environment, managing multiple
priorities.
- Employee may be required to lift objects up to 25lbs.Market
Range:$113,000 - $141,000Exact compensation may vary based on
skills, experience, and location.BenefitsShockwave Medical offers a
competitive total compensation package as well as the following
benefits and perks:Core Benefits: Medical, Dental, Vision, Pre-tax
and Roth 401k options with a fully vested match, Short-Term and
Long-Term Disability, and Life Insurance, Employer contribution
toward Health Savings Account (HSA), Competitive PTO balance.Perks:
Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus
awards.EEO Employer
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Keywords: Shockwave Medical, Inc., Santa Clara , Sr. R&D Engineer, Systems, Other , Santa Clara, California
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