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

Johnson & Johnson•New Brighton, MN

1d•$79,000 - $127,650

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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
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
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
Willingness to travel up to 10% of the time
Ability to lift objects up to 25 lbs

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