Manager, Sustaining Quality Engineering - Shockwave Medical - Santa Clara California

Company: Johnson & Johnson
Location: Santa Clara, California
Posted On: 02/02/2025

Job Description - Manager, Sustaining Quality Engineering - Shockwave Medical (2406226113W)Johnson & Johnson is recruiting for a Manager, Sustaining Quality Engineering (Hardware/Software) for Shockwave Medical Inc. 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.Position OverviewThe Manager, Sustaining Quality Engineering (HW/SW) provides leadership to the Sustaining Quality Engineering group and works closely with internal and external departments to efficiently deliver safe and effective medical devices to customers in compliance with Shockwave Medical (SWM) policies and procedures. This position will represent the hardware and software product life cycle management team. This position will support project teams to ensure that existing products are designed, developed and manufactured in accordance with customer, corporate, and regulatory guidelines and execute initiatives for continuity of supply chain, quality improvement, cost reduction, and product safety.Essential Job Functions

• Oversee all aspects of sustaining quality activities as it relates to Hardware, Software and Systems engineering.
• Oversee and manage Quality Engineers and Technicians supporting sustaining quality engineering activities.
• Hire, support, and mentor direct reports to develop a highly effective team.
• Set goals for Quality personnel based on corporate objectives.
• Ensure Quality Personnel follow regulations and industry standards.
• Provide visible leadership and oversees daily activities.
• Develop and maintain budget.
• Provide support to Manufacturing and Operations (either at internal site or at external vendor site).
• Establish and maintain validated processes.
• Identify, drive, and implement process improvements.
• Participate in Supplier Quality activities including supplier selection and audits.
• Work with contract manufacturers to maintain product quality and resolve any non-conformances that arise.
• Support business scalability and continuous improvement projects.
• Actively participate in Design Control/Design Change/Supplier Change activities.
• Ensure design transfers to manufacturing are completed successfully and in a compliant manner.
• Maintain Risk Management File documents.
• Ensure Sustaining projects and Design/Supplier Change activities are performed in compliance to regulations, standards, and internal procedures.
• Draft/Review/Perform Hardware and Software Verification and Validation Test Plan, Test Protocols, Methods, and Reports.
• Audit DHFs to ensure compliance to relevant procedures.
• Subject matter expert on application of relevant standards.
• Drive Standard Gap Assessment activities.
• Ensure compliance to new country requirements prior to product release.
• Investigate and document results for returned devices from clinical studies and commercial complaints.
• Maintain and manage the Servicing Program and coordinate servicing activities.
• Support Finished Goods distribution and commercial operations Quality activities.
• Support and assist in maintaining compliance with other areas of the QMS as needed.
• Analyze, review and present data for key Quality metrics.
• Initiate, review, and approve Document Change Orders (DCO).
• Participate in internal, supplier and third-party audits.
• 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 Electrical/Software Engineering. Master's Degree preferred.
  • 10+ years of hands-on experience with Hardware and Embedded Software Design, with a minimum of 8 years in the Medical Device industry.
  • Experience with Analog and Digital Circuit Design, schematic layouts, PCB Layout/design and prototype development.
  • Experience with embedded systems and programming.
  • 2+ years of experience managing others, or other equivalent experience.
  • Working knowledge of applicable medical device regulations and standards.
  • Experience with statistical software such as Minitab.
  • Experience with Class III medical device experience and electromechanical device product is highly desired.
  • Ability to understand regulatory implications of Design/Process/Supplier Changes.
  • Ability to lead cross-functional teams in problem solving and risk analysis activities.
  • Must be able to communicate effectively with all levels of the organization.
  • Highly proficient in MS Word, Excel and Power Point.
  • High attention to detail and accuracy is required.
  • 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.
  • Employee must be able to travel 25% of the time.Market Range: $144,000 - $180,000Exact compensation may vary based on skills, experience, and location.Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
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