Principal Quality Engineer (Hardware/Software) - Shockwave Medical

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

Job summary

A leading company in healthcare innovation is seeking a Principal Quality Engineer in Santa Clara, CA. This role focuses on ensuring the quality of medical devices through compliance with regulations and process improvements. The ideal candidate will have extensive experience in the medical device industry and a strong background in engineering principles. Join a team dedicated to pioneering advancements in healthcare technology and improving patient outcomes.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Performance Bonus

Vacation Time

Sick Time

Holiday Pay

Qualifications

• 10+ years of experience in Hardware and Software in Medical Device industry.
• Knowledge of ISO 13485, ISO 14971, 21 CFR Part 820 regulations.

Responsibilities

• Provide Sustaining Quality support to Manufacturing and Operations.
• Participate in Design Control activities and ensure compliance with regulations.
• Drive process improvements and manage Risk Analysis.

Skills

Communication

Problem Solving

Attention to Detail

Education

Bachelor of Science in Engineering

Master’s Degree

Tools

MS Word

Excel

Power Point

Minitab

Job description

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 (Hardware/Software)– Shockwave Medical to join our team 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. Learn more at https://www.jnj.com/.

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 will work closely with internal departments to efficiently support delivering safe and effective medical devices which are in line with Shockwave Medical Inc. (SWMI)/Johnson and Johnson policies and procedures. This position will represent Quality Assurance for hardware and software sustaining engineering activities to drive improvements with respect to hardware and equipment. 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, Manufacturing Engineering and Contract Manufacturers to improve processes where possible. 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, IEC 62304, IEC 62366 and IEC 60601.

Essential Job Functions

Provide Sustaining Quality support to Manufacturing and Operations:

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

• Assist in qualifying product manufacturing lines, molds, fixtures, tooling, and equipment

• Participate in Design/Manufacturing Site Transfer activities to internal and external manufacturing sites.

• Identify, drive, and implement process improvements.

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

• Work with contract manufacturers to maintain product quality and resolve any nonconformances that arise.

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

• Support hardware scalability and continuous improvement projects.

• Implement product changes effectively at Supplier Manufacturing site.

Actively participate in Design Control activities such as:

• Ensure new Design Transfer projects and Design Change activities are performed in compliance with external regulations, industry standards and internal procedures.

• Design reviews to document appropriate requirements per the Design and Development Plan are satisfied.

• Draft/Review Hardware and Software 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.

• Identify testing and analysis required to ensure conformance to product specifications.

• Drafting Software level of concern document and classification of Software modules. Software Risk mitigation methods.

• Audit DHFs to ensure compliance with the Design Control procedure.

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

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

• 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) 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.)

• 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.

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

• Other duties as assigned

Requirements

• A Bachelor of Science degree in a related Engineering discipline is required. Master’s Degree preferred.

• 10+ years of hands-on experience with Hardware and Software in the Medical Device industry is preferred.

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

• Working knowledge of IEC 62304, IEC 62366 and IEC 60601 is required.

• Familiarity with Analog and Digital Circuit Design, schematic layouts, PCB Layout/ design.

• Familiarity with embedded systems, Source version control, Issue Tracking, power and control electronics for use in medical devices and programming.

• Familiarity in establishing and managing contract manufacturers required.

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

• 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 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

• 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.

• Employees may be required to lift objects up to 25lbs.

Pay Transparency:

• The anticipated salary range for this position is $114,000 - $197,800

• 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)).

• This position is eligible to participate in the Company’s long-term incentive program.

• 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. https://www.careers.jnj.com/employee-benefits

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 and 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 email the Employee Health Support Center ([e-mail]) 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: