R&D Engineer II (Process Development)
Company: Shockwave Medical, Inc.
Location: Santa Clara
Posted on: September 21, 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
R&D Engineer II will use technical skills in the development of
innovative products to treat peripheral, coronary, and heart valve
diseases. The R&D Engineer II will focus on process development
for the engineering team, providing oversight to pilot
manufacturing/testing, and see products transition from development
into full production. This position will participate on multiple
cross-functional development teams that focus on process
optimization, sustaining, and design support. The R&D Engineer
II will develop, validate, and implement various processes by
working closely with research/development, operations, regulatory,
and quality teams.Essential Job Functions
- Support the development of product(s) for manufacturing in full
compliance with the company's Design Control requirements and
consistent with FDA, ISO, and MDR requirements.
- Work on prototype and develop designs, processes, and test
methods in support of new product designs scaling for
commercialization.
- Represent R&D on manufacturing-related project activities,
including internal and external requests.
- Analyze, evaluate, source, and coordinate the procurement of
new materials to support prototyping and pilot operation.
- Participate on cross-functional development team that manage
projects from concept through commercialization.
- Responsible for ensuring proper documentation consistent with
company's quality system.
- Responsible for knowing and planning activities consistent with
the company's quality policy and quality objectives.
- Responsible for ensuring the lab notebooks are documented in a
timely manner and consistent with the applicable SOP.
- Write protocols/reports and perform product verification and
validation testing.
- Perform process-related design tasks to support pilot
manufacturing.
- Identify suppliers and maintain relationships to ensure the
delivery of superior components and services.
- Responsible for component and assembly documentation for new
products being developed.
- Support company goals and objectives, policies and procedures,
Quality Systems, and FDA regulations.
- Other duties as assigned.Requirements
- Bachelor's degree in Mechanical or Biomedical Engineering with
2+ years' experience in engineering or a master's degree in
Mechanical or Biomedical Engineering with 1 year of engineering
experience preferred.
- Engineering experience in the medical device industry is highly
preferred.
- Knowledge of disposable peripheral and coronary device design,
material selection, and testing preferred.
- Strong understanding of engineering materials, component
selection, and design for reliability and manufacturability.
- Experience in early-stage catheter-based cardiovascular devices
development is a strong plus.
- Effective communication skills with all levels of management
and organizations.
- Ability to work in a fast-paced environment while managing
multiple priorities.
- Operate as a team and/or independently while demonstrating
flexibility to changing requirements.
- Employee may be required to lift objects up to 25lbs.Market
Range:$98,000 - $115,000Exact 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 , R&D Engineer II (Process Development), Engineering , Santa Clara, California
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