Johnson & Johnson is recruiting for a Manager, Sustaining Quality Engineering (Hardware/Software) for Shockwave Medical Inc. located in Quality 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/.  

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.

We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Position Overview

The 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. This position provides Quality Assurance support to functions with a focus on process validation, process improvements, post market sustaining activities, and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366 and IEC 60601.

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 such as:

• Ensure design transfers to manufacturing are completed successfully and in a compliant manner.

• Maintain Risk Management File documents such as Risk Management Plan, ongoing Risk Analysis, Failure Mode and Effects Analysis (FMEA), Risk Management Reports etc.

• 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, test sample sizes and usage of statistical techniques for sustaining and design/supplier/process change projects.

• 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 with internal and external parties.

• Support Finished Goods distribution and commercial operations Quality activities.

• Support and assist in maintaining compliance with other areas of the QMS as needed (Non-Conformance, Complaints, CAPAs, Post Market Surveillance, Management Responsibility, Supplier Controls, Audit Support, etc.)

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

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

• 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.

• Other duties as assigned.

Qualifications

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, source version control, Issue Tracking, and control electronics for use in medical devices and programming.

• 2+ years of experience managing others, or other equivalent experience.

• Working knowledge of applicable medical device regulations and standard such as ISO 13485, ISO 14971, IEC 62304, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP required.

• Experience with statistical software such as Minitab and the application of valid statistical techniques for data analysis.

• Experience with Class III medical device experience and electromechanical device product is highly desired.

• Experience and involvement with complaint investigations is preferred.

• 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 in both verbal and written formats.

• 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 - $180,000

Exact compensation may vary based on skills, experience, and location.

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 $141,000 to $227,700.

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)).

• 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.

For additional general information on Company benefits, please go to:   https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on January, 8, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.