Johnson & Johnson

Senior Quality Engineer, Design Assurance – Shockwave

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: New Brighton • Minnesota • United States

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Salary

💰 $79,000 - $127,650 per year

Job Level

Senior

About the role

  • Lead quality assurance for new product development
  • Partner with design teams to ensure compliance with ISO 13485 and applicable regulatory requirements
  • Serve as technical subject matter expert on regulatory standards, statistical methods, test design, and acceptance criteria
  • Participate in design reviews to provide an independent perspective on compliance and risk
  • Ensure Design History Files (DHFs) are complete, accurate, and inspection-ready throughout the development lifecycle
  • Develop and maintain Risk Management Files including plans/reports, hazard analyses, FMEAs, risk control strategies, and risk assessments
  • Support development and execution of incoming inspection plans, first article inspections (FAI), and related documentation to ensure alignment with design intent
  • Advise design teams on quality system and regulatory implications of design decisions and changes
  • Provide Design Assurance oversight for Verification and Validation (V&V) activities
  • Review and approve protocols, test methods, and reports
  • Provide quality oversight to ensure test strategies, acceptance criteria, and sample sizes are appropriate and compliant with applicable standards
  • Serve as a quality advisor for V&V activities including biocompatibility, sterilization validation, packaging validation, and shelf‑life studies
  • Lead or support test method validation (TMV) activities to ensure methods are suitable for their intended use and comply with internal and regulatory expectations
  • Perform or witness hands-on Design V&V testing when needed to support design assurance assessments
  • Partner with to Manufacturing and Operations on design transfer and validation
  • Support equipment and process validation activities (IQ/OQ/PQ) associated with new product introduction
  • Ensure manufacturing processes, controls, and validations support design intent and regulatory requirements
  • Support Contract Manufacturing and Supplier Quality in identifying, qualifying, and managing suppliers during product development.
  • Participate in FDA, Notified Body, and ISO 13485 audits/inspections
  • Contribute to regulatory submissions (510(k), CE Technical Files, PMA modules)

Requirements

  • Degree in biomedical/mechanical engineering (or related field) – bachelor’s with 5+ years or master’s with 3+ years of medical device industry experience
  • Demonstrated hands-on experience across: Design Verification and Validation (V&V), including review and approval of protocols and reports
  • Test Method Validation (TMV), including development, execution, or quality oversight of validated methods
  • Risk Management in accordance with ISO 14971
  • Failure Modes and Effects Analysis (FMEA) development and management
  • Working knowledge of applicable medical device quality system and regulatory requirements as they apply to design and development activities, including ISO 13485, ISO 14971, 21 CFR Part 820 / FDA QMSR, and EU MDR (2017/745)
  • Strong statistical and analytical skills, including hypothesis testing, sample size determination, and data analysis
  • Proficiency with statistical software (e.g., Minitab or equivalent)
  • Strong technical writing skills for quality-related documentation, including protocols, reports, and design history records.
  • Clear and effective communicator, able to convey technical and quality concepts to diverse audiences.
Benefits
  • Health insurance
  • 401(k) matching
  • Paid time off
  • Vacation –120 hours per calendar year
  • Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
  • Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
  • Caregiver Leave – 80 hours in a 52-week rolling period
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Design Verification and Validation (V&V)Test Method Validation (TMV)Risk ManagementFailure Modes and Effects Analysis (FMEA)Statistical methodsHypothesis testingData analysisQuality oversightDesign History Files (DHF)Risk assessments
Soft Skills
Strong technical writing skillsClear communicationAnalytical skillsInterpersonal skillsLeadershipCollaborationProblem-solvingAttention to detailIndependent perspectiveAdvisory skills