R&D Engineer I (Clinical Engineering) - Shockwave Medical

Johnson & Johnson Innovative Medicine•Santa Clara, CA

2d•$73,000 - $117,300

About The Position

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 https://www.jnj.com/. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s 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 Medical’s innovative platform and technology of current and future products.

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

Responsibilities

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.
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.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year