Johnson & Johnson MedTech · 9 hours ago
Sr. Design Quality Engineer- Shockwave Medical
Santa Clara, CA
Full-time
Onsite
Mid, Senior Level
$106K/yr - $164K/yr
5+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, focusing on developing advanced medical solutions. They are seeking a Sr. Design Quality Engineer to ensure compliance with medical device regulations and support the development of safe and effective medical device designs for Shockwave Medical's innovative portfolio.
Hospital & Health Care
Responsibilities
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 & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team
Other duties as assigned
Qualification
Required
Bachelor's 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
Ability to lead cross-functional teams in problem solving and risk analysis activities
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
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
Preferred
Experience and involvement with complaint investigations, including MDRs and Vigilance Reporting is preferred
Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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