Jobs for People with MS: National MS Society

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) – Shockwave Medica l 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 (Hardware) works closely and partners with internal/external departments to efficiently deliver safe and effective medical device designs for manufacturing, which are in line with Shockwave Medical Inc. (SWMI) policies and procedures. This position will represent Quality Assurance for Hardware design, development, and support sustaining engineering 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 and Manufacturing Engineering 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

• Actively participate in Design Control activities such as:

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

• Design reviews to document and ensure that the design meets the intended customer requirements.

• Develop/Review/Perform Hardware Design Verification and Validation Test Plan, Test Protocols, and Reports.

• Subject Matter Expert on application of relevant standards, test sample sizes and usage of statistical techniques for new Design and Development Projects.

• Lead and responsible for Risk Management files documents such as Risk Management Plan, Risk Analysis, Failure Mode and Effects Analysis (FMEA), Risk Management Reports.

• Perform Design Verification and Validation Testing.

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

• Audit DHFs to ensure compliance with Design Control procedure.

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

• Assist in qualifying molds, fixtures, tooling, and equipment.

• Perform/support process validations, identify, drive, and implement process improvements.

• Support ongoing Regulatory submission activities and product approval processes.

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

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

• Provide support to Manufacturing and Operations.

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

• 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.

• Drive Standard Gap Assessment activities.

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

• 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/Electronic Engineering with 10+ years of hands-on experience with Hardware Design and Development, System of System Design Verification and Validation Testing in the Medical Device industry or an MS with 8+ years of hands-on experience with Hardware Design and Development, System of System Design Verification and Validation Testing in the Medical Device industry. Master’s Degree preferred.

• Working knowledge of applicable medical device regulations and standards such as ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP required.

• Familiarity with Analog and Digital Circuit Design, schematic layouts, PCB Layout High Voltage circuit/ design, develop automatic testing code, MATLAB, LabView and prototype development.

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

• Electromagnetic compatibility (EMC) and Underwriters Laboratories (UL) Electrical Safety experience is required.

• Design experience with FPGA’s using VHDL or Verilog is required.

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

• Experience in catheter based cardiovascular devices development is a strong plus.

• Ability to perform multiple tasks concurrently with accuracy.

• Ability to understand regulatory implications of Design Changes.

• Experience and involvement with complaint investigations.

• Ability to lead cross-functional teams in problem solving and risk analysis activities.

• 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.

• Proficiency in MS Word, Excel and Power Point required.

• Employee 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 (ra-employeehealthsup@its.jnj.com) 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: