Senior Quality Engineer, Design Assurance – Shockwave

Role Overview

• 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