Staff Quality Engineer - Shockwave Medical

Staff Quality Engineer – Shockwave Medica

Johnson & Johnson is hiring for a Staff Quality Engineer – Shockwave Medica 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.

The Staff Quality Engineer (Design Assurance) 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. 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 applicable 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 to Design Control procedure.
• 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.
• Responsible for ongoing management of Risk Analysis, Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA.), Risk Management Plans and Reports.
• Perform 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
• Human Factors Formative and Summative evaluation
• Restricted Substance Control and Approved Supplier List
• Identify testing and analysis required for the finished device to ensure conformance to product specifications.

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

Establish Post Market Surveillance plan in coordination with Post Market Surveillance team.

Audit DHFs to ensure compliance to 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-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 Post Market Surveillance Reports and update Risk Management Reports on periodic basis.

Review, investigate, disposition, and drive to completion Non-conforming Reports (NCR) 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 Gap Assessment activities.

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

Work alongside Regulatory to interpret regulations and 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.

Other duties as assigned.

Requirements:

• Bachelor of Science degree in a related engineering discipline and 8+ years of medical device industry experience; or Master of Science in a related engineering discipline and 5+ years of medical device industry experience
• Working knowledge of applicable medical device regulations such as ISO 13485, ISO 14971, IEC 62366, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP required.
• Ability to perform multiple tasks concurrently with accuracy.
• Ability to understand regulatory implications of Design Changes.
• Experience and involvement with complaint investigations is preferred.
• Participate in cross-functional team efforts 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
• 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/or Statgraphics 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: $105,000 - $169,050

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.