Principal Quality Engineer

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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

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.

Essential Job Functions

• Actively participate in Design Control activities such as:

  • Ensure new Design projects and Design Change activities are performed in compliance with Design Control procedure and relevant regulatory/user requirements.

  • Design reviews to document and ensure that the design meets the intended customer requirements.

  • Draft Design Verification and Validation Test Protocols, Methods and Reports.

  • Subject Matter Expert on application of relevant standards, test sample sizes and usage of statistical techniques for new Design and Development Projects.

  • Lead and responsible for ongoing management of Risk Analysis, Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA.), Risk Management Plans and Reports.

  • Perform periodic review and update of Post Market Surveillance data to ensure it is aligned with Product Risk Management Files.

  • Oversee Design Verification and Validation Testing.

  • Lead/coordinate/perform verification/ validation activities for:

    •  Biocompatibility Testing.

    • Packaging Validation.

    • Accelerated and Real Time Shelf-Life/Aging Studies.

    • Sterilization Validation.

    • Test Method Validation.

  • Identify testing and analysis required for the finished device to ensure conformance to product and user specifications.

  • Develop device Quality Plans to ensure that the elements of the Quality Management System are appropriately described and managed.

  • Audit DHFs to ensure compliance with Design Control procedure.

  • Provide support to Manufacturing and Operations:

    • Perform or assist in root cause analysis of product non-conformances found in manufacturing.

    • Assist in qualifying molds, fixtures, tooling, and equipment.

    • Perform/support process validations.

    • Identify, drive, and implement process improvements.

    • Participate in Supplier Quality activities including material non-conformances and Supplier audits.

    • Work with contract manufacturers to maintain product quality and resolve any non[1]conformances that arise.

    • Recommend QC sampling plans based on desired confidence and reliability limits.

• Evaluate/investigate and document investigation results for returned devices from clinical studies and commercial complaints.

• Review, investigate, disposition, and drive to completion Non-conforming Reports (NCR), Audit Findings and Corrective and Preventive Actions (CAPA.)

• Analyze and review data for key Quality metrics to identify any significant trends.

• Initiate, review, and approve Document Change Orders (DCO.)

• Drive Standard Gaps Assessment activities.

• Participate in internal, supplier and third-party audits (FDA, FDB, Notified Body, etc.)

• Support ongoing Regulatory submission activities and product approval processes.

• Participate in the implementation and continuous improvement of the Quality Management System.

• Provide technical support to the Quality inspection group.

• J&J Credo: Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

• Other duties as assigned

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.

The anticipated base pay range for this position is :

$114,000 - $197,800

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. 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. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits