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JOB DESCRIPTION:

Johnson & Johnson is hiring for a Principal Quality Engineer – Shockwave Medical to join our team located in Santa Clara, CA.
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 Principal Quality Engineer works closely and partners with internal departments to efficiently deliver safe and effective medical device designs for manufacturing, which are in line with Shockwave Medical Inc. (SWMI) policies and procedures. The QE provides Quality Assurance support to functions with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP and other relevant standards/regulations. This includes supporting project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines as well as working closely with Design and Manufacturing Engineering to improve processes where possible.

REQUIREMENTS

• Bachelor of Science degree in Engineering. Master’s Degree is preferred.
• Experience with Software and Hardware Validations is a plus.
• 10+ years of hands-on experience working as an engineer in the Medical Device industry.
• Working knowledge of applicable medical device regulations such as ISO 13485, ISO 14971, ISO 11137, ISO 10993, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP required.
• Working knowledge of IEC 62304, IEC 62366 and IEC 60601 is preferred.
• Ability to perform multiple tasks concurrently with accuracy.
• Ability to understand regulatory implications of Design Changes.
• Experience and involvement with complaint investigations, including MDRs and Vigilance Reporting is preferred.
• Ability to take a hands-on approach and lead cross-functional teams in problem solving and risk analysis activities
• Must have demonstrated hands-on experience in:
• Design Verification and Validation.
• Hazard/Risk Analysis.
• Design/Usability/Process FMEA.
• Reliability and Stability Testing.
• FDA Good Manufacturing Practices (GMP).
• Clear and effective communication skills
• Must be able to communicate effectively with all levels of the organization in both verbal and written formats
• Proficiency in MS Word, Excel and Power Point required
• High attention to detail and accuracy is required
• Experience with statistical software such as Minitab and the application of valid statistical techniques for data analysis.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Employee may be required to lift objects up to 25lbs.
  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 https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Please refer the Job description for details