Research Scientist I

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 Research Scientist I is responsible for assisting in all ongoing preclinical projects both in vitro and in vivo and will help gather data to evaluate and improve the current products/delivery system. In addition, this person will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. This person will be working with a multidisciplinary team of Scientists and Engineers to optimize the current platform. This is a hands-on role within the Clinical Engineering team and represents a unique opportunity to operate within a focused pre-clinical studies group to manage studies to support the development of Shockwave Medical’s innovative platform and technology of current and future products.   

Essential Job Functions  

• Support the design and development of product(s) in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDD requirements.
• Participate on cross-functional development teams that manage projects from concept through commercialization.
• Support procedure room activities for data collection, monitoring and device accountability.
• Support pre-clinical testing and assist in developing pre-clinical research protocols and reports.
• Review and author study protocols for in-vitro and in-vivo studies.
• Maintain preclinical laboratory equipment and supplies, ensuring proper calibration (if necessary) is conducted accordingly.
• Must have excellent organizational skills and be able to record and manage experimental data from various experimental studies ongoing concurrently.
• Support regulatory efforts through understanding of relevant standards and interpretation of FDA Guidance documents.
• May require active participation in research meetings, including making detailed scientific presentations pertaining to study.
• Work cooperatively with a multidisciplinary team of Scientists, Engineers, and Regulatory personnel in other departments.
• Contribute to hands-on in vitro laboratory work as needed, which may include isolated tissue experiments, including all necessary precautions for tissue work.
• Other duties as assigned.

Requirements  

• B.S. in Biomedical or Mechanical Engineering, Biology, Physiology or related field with at 0-2 years of relevant experience OR a M.S. in Biomedical Engineering, Biology, Physiology or related field. Advanced degree preferred
• Research experience with large (non-rodent) animal models preferred
• Must be able to travel to CROs for conducting studies (up to 10%)
• Previous experience with large animal studies in a regulated medical device environment preferred
• Previous experience with study protocols and process preferred
• Experience in design control processes for medical device performance testing and development is desirable
• Ability to work independently and take ownership of tasks assigned
• Effective written and oral communication skills
• Ability to work in a fast-paced environment; learn and become familiar with techniques in both the engineering and biological sciences
• Familiarity with basic animal lab techniques and precautions preferred
• Microsoft Office (Word, Excel, Powerpoint)
• Experience with data analysis tools such as Minitab and graphing software such as GraphPad Prism preferred

Market Range: $98,000 - $115,000 

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