Fueled by innovation at the intersection of biology and technology, we92re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that92s 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 Sr. Design Quality Engineer (Embedded Software and Hardware System Verification & Validation) works closely and partners with internal 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 Design Engineering Assurance for hardware and embedded software design, development, design system verification and validation and support sustaining engineering to drive improvements with respect to hardware, software, 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

• Ensures new Design projects and Design Change activities are performed in compliance with medical device regulations, standards, and internal procedures.
• Participates in Design reviews to document and ensure that the design meets the intended customer requirements.
• Develops/Reviews/Performs Embedded Software and Hardware System Design Verification and Validation Test Plan, Test Protocols, and Reports.
• Is a Subject Matter Expert on application of relevant standards, usage of statistical techniques for new Design and Development Projects.
• Responsible for Risk Management files documents such as Risk Management Plan, Risk Analysis, Failure Mode and Effects Analysis (FMEA), Risk Management Reports.
• Develops device Quality and System V&V Plans to ensure that the elements of the Quality Management System is appropriately described and managed.
• Provides Software level of concern and classification of Software modules.
• Audits DHFs to ensure compliance with the Design Control procedure.
• Assists in qualifying molds, fixtures, tooling, and equipment.
• Perform/support process validations, identify, drive, and implement process improvements.
• Supports ongoing Regulatory submission activities and product approval processes.
• Identifies testing and analysis required to ensure conformance to product specifications.
• Supports hardware scalability and continuous improvement projects
• Initiates, reviews, and approves Document Change Orders (DCO.)
• Provides support for Manufacturing and Operations.
• Works with contract manufacturers to maintain product quality and resolve any non-conformances that arise.
• Performs or assists in root cause analysis of product non-conformances found in manufacturing.
• Evaluates/investigates and documents investigation results for returned devices from clinical studies and commercial complaints.
• Reviews, investigates, dispositions, and drives to completion Non-conforming Reports (NCR) and Corrective and Preventive Actions (CAPA.)
• Analyzes and reviews data for key Quality metrics to identify any significant trends.
• Drives Standard Gap Assessment activities.
• Participates in internal, supplier and third-party audits (FDA, FDB, Notified Body, etc.)
• Participates in the implementation and continuous improvement of the Quality Management System.
• Provides technical support to the Quality inspection group.
• Recommends QC sampling plans based on desired confidence and reliability limits.
• Participates in Supplier Quality activities including material non-conformances and Supplier audits.
• J&J Credo: Understands and applies Johnson & Johnson92s Credo and Leadership Imperatives in day-to-day interactions with team.
• Other duties as assigned

Requirements

• Bachelor92s in software/electrical engineering with 5+ years of hands-on experience with Embedded Software, Hardware Design and Development.
• System of System Design Verification and Validation Testing in the Medical Device industry or an MS with 3+ years of hands-on experience with Embedded Software, Hardware Design and Development, System of System Design Verification and Validation Testing in the Medical Device industry.
• Working knowledge of applicable medical device regulations and standard 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.
• Experience with Analog and Digital Circuit Design, schematic layouts, PCB.
• Layout/ design, prototype development, automation tests, server component validation, stress, and reliability tests.
• Experience with design and development of embedded systems, Source version control, Issue Tracking, power, and control electronics for use in medical devices and programming experience is highly desired.
• Responsible for design component and assembly documentation for new products being developed
• Class III medical device experience and electromechanical device product
• 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
• 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.
• Employee may be required to lift objects up to 25lbs.
• 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
• Employee may be required to lift objects up to 25lbs

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Additional Information

• 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 corporation92s performance over a calendar/performance year. Bonuses are awarded at the Company92s 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 Company92s consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
  • Vacation 93 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 93 up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays 93 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.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

Additional Description for Pay Transparency: