Principal R&D Engineer (Balloon Technology)

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.

• Provide technical leadership for projects including managing technology development teams
• Design and develop product(s) in compliance with the company's Design Control requirements and consistent with applicable regulatory requirements.
• Partner with the Adv. R&D and PDP teams to translate finished device requirements to the balloon component level
• Survey emerging technologies in the balloons and polymer science space and explore novel applications to support company strategic goals
• Identify practical ways to apply new balloon/polymer technologies to improve current and next generation products
• Execute a long-term strategy with Technologies Development Team for examining new designs, materials as well as processing methods for next-generation balloon concepts
• Prototype and develop proof of concept designs, disease models and test methods of testing these concepts in a simulated environment and develop new product designs based on the defined user needs.
• 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.
• Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping and pilot operation as well as to maintain relationships with suppliers to ensure the delivery of superior components and services.
• Participate as SME or core team member on product development team(s) that manage projects from concept through commercialization.
• Responsible for ensuring proper documentation (e.g., component and assembly drawings) consistent with company's quality system.
• Responsible for knowing and planning activities consistent the company's quality policy and quality objectives.
• Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.
• Enhance the intellectual property position of the company via invention disclosures and patent applications.
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company's products.
• Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.
• Other duties as assigned.

• Bachelor's Degree in Mechanical Polymer Science or other relevant engineering/technical degree and 10 years' experience in the medical device industry or a Master's Degree and 8 years' experience in medical devices.
• 3+ years of experience in polymer product development including experience with balloon blow molding.
• Knowledge of disposable peripheral and coronary device design, material selection, and testing.
• Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
• Proven track record in technology development and/or early-stage R&D; capable of planning and executing tasks for progressing towards a loosely defined research goal.
• Proven successful project leadership skills.
• Effective communication skills with all levels of management and organizations.
• Ability to operate independently and adaptability to changing requirements.
• Ability to work in a fast-paced environment, managing multiple priorities.
• Previous experience managing cross functional teams is preferred.
• Proficiency in SOLIDWORKS and Design of Experiments is a strong plus.
• Employee may be required to lift objects up to 25lbs.

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