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
Job Function:
R&D Product Development
Job Sub Function:
Biomedical Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
Santa Clara, California, United States of America
Job Description:
Johnson & Johnson is hiring for a R&D Engineer II (Clinical Engineering) – 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.
The R&D Engineer II (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 current platforms. 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 support the development of Shockwave Medical’s innovative platform and technology.
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.
- 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.
- Analyze, evaluate, source, 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.
- Drive procedure room activities for data collection, monitoring and device accountability.
- Drive 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.
- Drive 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
- Bachelor’s Degree in Biomedical or Mechanical Engineering, Biology, Physiology or related field with a minimum of 3 years of relevant experience or a Master’s Degree with a preferred minimum of 1 year of relevant experience.
- 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.
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.
The anticipated salary range for this position is $86,000-$138,000
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be 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.
- Employees are eligible for the following time off benefits:
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
- Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
The anticipated base pay range for this position is :
$86,000-$138,000
Additional Description for Pay Transparency:
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