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.
Position Overview
The Principal R&D Engineer will use technical and leadership skills in the development of innovative products to treat coronary and peripheral vascular disease with potential to expand to other vascular diseases. The Principal R&D Engineer will participate on multiple cross-functional development teams that manage projects from concept through commercialization, with a primary focus on early-stage / phase-zero development. This role will serve as technical lead for the early-stage development period of projects.
Essential Job Functions
- Provide technical leadership for projects in the coronary and peripheral vascular space.
- Provide mentorship to other engineers and assignments to technicians as required.
- Collaborate cross-functionally to gather and define user needs for new products
- Prototype and develop proof of concept designs, disease models and test methods based on the defined user needs and requirements.
- Solve challenging and complex technical problems during the new product development process.
- Work with clinical and scientific advisors as well as Key Opinion Leaders in translating clinical needs into design solutions while utilizing these resources to develop and optimize product design.
- Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation.
- Develop protocols, test methods, and reports, and perform product assessments on benchtop, in-situ, and in-vivo to prove and de-risk viability and feasibility of new product designs.
- Identify suppliers and maintain relationships to ensure the delivery of superior components and services.
- Enhance the intellectual property position of the company via invention disclosures and patent applications.
- Participate as SME on product development team(s) that manage projects from concept through transfer to PDP team.
- Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable regulatory requirements.
- Ensure proper documentation consistent with the company's quality system.
- Responsible for knowing and planning activities consistent with the company's quality policy and quality objectives.
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company's products.
- 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 (or similar) Engineering and 10 years' experience in engineering OR a Master's Degree and 8 years' experience in engineering OR a PhD and 6 years' experience in engineering.
- 3 years' experience in early-stage (pre-design freeze) catheter and/or leads-based cardiovascular device development, preferred.
- Knowledge of coronary and vascular anatomy, physiology, and model development is a strong plus.
- Minimum 1 year as team or project technical lead.
- Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
- Strong understanding of data analysis and statistics including design of experiments, Gage R&R, capability, etc. is a strong plus.
- Strong teamwork skills and demonstrated ability to work closely with cross functional partners.
- Effective communication skills with all levels of management and organizations.
- Operate independently and adaptability to changing requirements.
- Ability to work in a fast-paced environment, managing multiple priorities.
- Occasional travel up to 10%
- Employee may be required to lift objects up to 25 lbs.
Market Range: $144,000 - $180,000
Exact compensation may vary based on skills, experience, and location. Benefits
Shockwave 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 |
Shockwave Medical
life insurance, 401(k)
Nov 09, 2024