R&D Engineer I (Clinical Engineering) Shockwave Medical

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at

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Johnson & Johnson is hiring for a R&D Engineer I Shockwave Medical to join our team located in Santa Clara CA.

At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio 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 R&D Engineer I (Clinical Engineering) 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 Medicals 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 companys Design Control requirements and consistent with FDA ISO and MDD requirements.

• Support the prototype and development of proof-of-concept designs disease models and test methods for evaluation in a simulated environment and support new product designs based on the defined user needs.

• Assist in the analysis evaluation sourcing and coordinate the procurement of new materials to support prototyping and pilot operation.

• 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. or M.S. in Biomedical or Mechanical Engineering Biology Physiology or related field (Advanced degree preferred)

• Strong foundation in basic science including engineering principles anatomy and physiology

• 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

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please contact us via or contact AskGS to be directed to your accommodation resource.

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