Address
Form of work
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.
Description
Position Overview
The Sr. R&D Engineer will be responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures for in-house balloon blowing, from design to production. The Sr. R&D Engineer will support product development efforts in our IVL balloon related devices as well as develop new balloon technologies to address the anticipated needs of future applications. The position will also support the manufacturing line as well as improvements, modifications, and deployment of sustaining production lines of Catheter products.
Essential Job Functions
- Provide technical leadership for projects including polymer tubing extrusion, blow molding, balloon forming, reflowing and tipping and catheter design
- Design and develop product(s) in compliance with the company’s Design Control requirements and consistent with applicable regulatory requirements.
- Partner with R&D 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
- With guidance from the team, execute a long-term strategy 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.
- Design and fabricate test fixtures to verify catheter functional requirements
- Analyze, evaluate, source, and coordinate 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 a 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.
- Evaluate suppliers for technology and engineering capabilities and methods.
- Evaluate existing engineering processes and recommends improvements.
- 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.
Requirements
- Bachelor’s Degree in Mechanical Engineering, Polymer Science or other relevant engineering degree and 5+ years’ experience in the medical device industry or a Master’s Degree in Mechanical Engineering, Polymer Science or other relevant engineering degree and 3+ years’ experience in the medical device industry.
- 2+ years of experience in polymer product development including experience with balloon blow molding
- Knowledge of manufacturing processes related to both compliant and non-compliant balloons
- Knowledge of polymer tubing extrusion, blow molding, balloon forming, material selection, and testing
- Strong understanding of engineering materials, component selection, and design for reliability and manufacturability
- Experience in technology development and/or early-stage R&D; capable of planning and executing tasks for progressing towards a loosely defined research goal
- Successful project leadership skills
- Proficient in written and verbal communication, including creating and delivering presentations
- Effective communication skills with all levels of management and organizations
- Ability to work in a fast-paced environment, managing multiple priorities
- Proficiency in SOLIDWORKS and Design of Experiments is a strong plus
- Employee may be required to lift objects up to 25lbs
Market Range: $113,000 - $141,000
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: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer
