Principal Quality Engineer (Hardware/Software) - Shockwave Medical

Jnjmedtech; Santa Clara (CA); On-site; USD 114,000 - 198,000; Full time

Job summary

A leading company in medical technology is seeking a Principal Quality Engineer to ensure compliance and quality assurance for hardware and software in medical devices. The role involves collaborating with various departments to optimize processes and uphold regulatory standards. Candidates should have extensive experience in medical devices, strong problem-solving skills, and a relevant engineering degree.

Benefits

Competitive compensation

Performance bonuses

Benefits and retirement plans

Qualifications

• 10+ years experience with hardware and software in medical devices preferred.
• Knowledge of medical device regulations (ISO 13485, ISO 14971, 21 CFR 820).
• Experience with Class III devices and electromechanical products is highly desirable.

Responsibilities

• Perform root cause analysis of product non-conformances in manufacturing.
• Ensure design transfer projects comply with regulations and internal procedures.
• Support regulatory submissions and continuous QMS improvement.

Skills

Problem-solving

Communication

Multitasking

Education

Bachelor’s degree in a related Engineering field

Master’s preferred

Tools

MS Office

Statistical software (e.g., Minitab)

Job description

Principal Quality Engineer (Hardware/Software) - Shockwave Medical

Join to apply for the Principal Quality Engineer (Hardware/Software) - Shockwave Medical role at Johnson & Johnson MedTech.

About Johnson & Johnson MedTech

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.

Position Overview

The Principal Quality Engineer will work closely with internal departments to support the delivery of safe and effective medical devices, ensuring compliance with Shockwave Medical Inc. (SWMI)/Johnson & Johnson policies and procedures. This role represents Quality Assurance for hardware and software sustaining engineering activities, driving improvements related to hardware and equipment. The engineer will support project teams to ensure new and existing products meet customer, corporate, and regulatory standards, working closely with Design, Manufacturing Engineering, and Contract Manufacturers to optimize processes. Compliance with standards such as ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366, and IEC 60601 is essential.

Essential Job Functions

Provide Sustaining Quality Support to Manufacturing and Operations

• Perform root cause analysis of product non-conformances in manufacturing.
• Assist in qualifying manufacturing lines, molds, fixtures, tooling, and equipment.
• Participate in Design/Manufacturing Site Transfer activities.
• Identify and implement process improvements.
• Engage in Supplier Quality activities, including material non-conformances, supplier qualification, and audits.
• Collaborate with contract manufacturers to maintain quality and resolve issues.
• Recommend QC sampling plans based on confidence and reliability.
• Support hardware scalability and continuous improvement projects.
• Implement product changes effectively at supplier sites.

Design Control Activities

• Ensure design transfer projects and change activities comply with regulations and internal procedures.
• Conduct design reviews and document requirements per the Design and Development Plan.
• Draft and review hardware and software verification and validation protocols and reports.
• Apply standards, test sample sizes, and statistical techniques for new projects.
• Identify testing and analysis needs for conformance.
• Draft software concern documents, classify software modules, and develop risk mitigation methods.
• Audit DHFs for compliance.
• Manage risk analyses, FMEA, FTA, and risk management plans.
• Develop device Quality Plans.
• Investigate device complaints and returned devices.
• Review NCRs and CAPAs, analyze quality metrics for trends.
• Manage Document Change Orders and participate in audit activities.
• Support regulatory submissions and continuous QMS improvement.
• Provide technical support to Quality inspection teams.
• Uphold Johnson & Johnson’s Credo and Leadership principles.

Requirements

• Bachelor’s degree in a related Engineering field; Master’s preferred.
• 10+ years experience with hardware and software in medical devices (preferred).
• Knowledge of medical device regulations (ISO 13485, ISO 14971, 21 CFR 820, etc.).
• Familiarity with circuit design, embedded systems, and contract manufacturing.
• Experience with Class III devices and electromechanical products is highly desirable.
• Strong problem-solving, communication, and multitasking skills.
• Proficiency in MS Office, statistical software (e.g., Minitab), and data analysis techniques.

Additional Information

The salary range is $114,000 - $197,800. We offer competitive compensation, performance bonuses, benefits, and retirement plans. For more details, visit https://www.careers.jnj.com/employee-benefits. Johnson & Johnson is an Equal Opportunity Employer and supports inclusive hiring practices.