Sr. Quality Engineer, Design Assurance – Shockwave (Reducer)

Johnson & Johnson Innovative Medicine • Minneapolis, MN

2d • $79,000 - $127,650

About The Position

Johnson & Johnson is hiring for a Sr. Quality Engineer, Design Assurance – Shockwave (Reducer) to join our team located in New Brighton, MN. Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the innovative Shockwave Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina – long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide. To support the growing Shockwave Reducer business, we are establishing a facility in New Brighton, MN focused on the Reducer. We are actively seeking motivated individuals who bring relevant industry experience and are enthusiastic about learning and growing within the Reducer business. Learn more at https://www.jnj.com/. Position Overview The Senior Quality Engineer (Design Assurance) is responsible for ensuring medical devices are designed, developed, and transferred to manufacturing in compliance with applicable quality system and regulatory requirements. This role partners closely with R&D, Manufacturing, Regulatory Affairs, Clinical Affairs, and Marketing to provide hands-on Design Assurance support throughout new product development. This role applies and interprets relevant medical device standards and regulations as they related to design and development activities to advise design teams on quality and compliance impacts of design decisions, ensures robust design controls, and maintains Design History Files (DHFs). As a senior individual contributor, this position provides practical, execution‑focused quality engineering support with an emphasis on risk management, verification and validation oversight, and design transfer, enabling timely and compliant product launches.

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
• Application of FDA GMP and ISO 13485 requirements within a design and development environment
• Regulatory & Technical Knowledge: 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
• Core Competencies: Demonstrated ability to manage multiple complex development activities simultaneously while maintaining attention to detail and compliance
• Strong cross-functional collaboration skills, with the ability to effectively partner with stakeholders
• Self-directed and accountable, with the ability to independently execute assigned responsibilities and follow through on commitments
• Experience supporting regulatory inspections and audits (FDA, Notified Body, ISO) through preparation, participation, and response development
• Clear and effective communicator, able to convey technical and quality concepts to diverse audiences

Nice To Haves

• Experience supporting development of Class II or Class III medical devices, preferably within cardiovascular or interventional product areas
• Familiarity with balloon catheter, interventional, or sterile single-use devices
• Experience contributing to quality activities supporting regulatory submissions (e.g., 510(k), CE Technical Files, PMA modules)
• Working experience supporting biocompatibility and sterilization activities within a design and development environment
• Hands-on experience with PLM systems (e.g., Windchill) and manufacturing execution systems (MES)
• Experience supporting manufacturing readiness and transfer activities for new product introductions, including associated validation efforts
• Knowledge of human factors and usability engineering principles (e.g., IEC 62366-1)
• Lean, Six Sigma or Design for Six Sigma certification

Responsibilities

• 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)
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• Perform additional duties as assigned, contributing to team success.

Benefits

• Subject to the terms of their respective plans, employees are 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.
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: 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 period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year
• For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees