Staff R&D Engineer

Shockwave Medical • Saint Paul, MN

383d • $107,000 - $134,000

About The Position

The Staff R&D Engineer at Shockwave Medical will leverage technical expertise to develop innovative medical devices aimed at treating advanced cardiovascular diseases. This role involves collaboration on cross-functional teams, managing projects from initial concept through to commercialization, and ensuring compliance with regulatory requirements.

Requirements

• Bachelor's Degree in Mechanical or Biomedical Engineering with 8 years' experience in engineering or a Master's Degree in Mechanical or Biomedical Engineering and 6 years' experience in engineering.
• Engineering experience in the medical device industry.
• Knowledge of disposable peripheral and coronary device design, material selection, and testing.
• Experience in design and development of cardiovascular implants and delivery systems (stents, heart valves, etc.).
• Experience with balloon expandable and/or self-expanding implants is a plus.
• Experience with implant finite element analysis and durability testing is a plus.
• 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.
• Experience with CAD software (i.e. Solidworks).
• Experience with statistical analysis and design of experiments (DOE) is a plus.
• Effective communication skills, written and verbal, with all levels of management and organizations.
• Ability to operate independently and adapt to changing requirements.
• Ability to work in a fast-paced environment, managing multiple priorities.
• Experience developing disposable medical devices.

Nice To Haves

• Experience with balloon expandable and/or self-expanding implants.
• Experience with implant finite element analysis and durability testing.
• Experience with statistical analysis and design of experiments (DOE).

Responsibilities

• Design and develop products in compliance with the company's Design Control requirements and applicable regulatory requirements.
• Prototype and develop proof of concept designs and bench models to test these concepts in a simulated environment.
• Develop, validate, and maintain test methods.
• Translate user needs into design inputs/product specifications.
• Develop and maintain technical documentation such as drawings for components and assemblies for products.
• Support the design, development, and qualification of products, equipment, and processes.
• Perform testing, analyze results, and provide recommendations for design selection.
• Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and design verification activities.
• Develop protocols/reports and perform product in-vitro, in-vivo, as well as verification and validation testing.
• Participate in technical design reviews to ensure all design inputs and user needs are met.
• Support product development teams in executing projects from concept to commercialization.
• Support base business and/or continuous improvement projects.
• Ensure proper documentation consistent with the company's quality system.
• Support pilot manufacturing as necessary.
• Identify and maintain relationships with suppliers to ensure the delivery of superior components and services.
• Enhance the intellectual property position of the company via invention disclosures and patent applications.
• Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.

Benefits

• Medical, Dental, Vision insurance
• Pre-tax and Roth 401k options with a fully vested match
• Short-Term and Long-Term Disability
• Life Insurance
• Employer contribution toward Health Savings Account (HSA)
• Competitive PTO balance
• Calm App
• Pet Insurance
• Student Loan Refinancing
• Spot Bonus awards

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree