Principal Quality Engineer - Johnson & Johnson MedTech, Circulatory Restoration (Shockwave Reducer)

Johnson & Johnson Innovative Medicine•New Brighton, MN

13d•$102,000 - $177,100•Onsite

About The Position

Johnson & Johnson is hiring a Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business in New Brighton, Minnesota. The role ensures medical devices are designed, developed, and transferred to manufacturing in compliance with applicable quality-system and regulatory requirements. It partners with Research and Development, Manufacturing, Regulatory Affairs, Clinical Affairs, and Marketing to provide hands-on Design Assurance support throughout new product development. The position applies and interprets medical-device standards and regulations, advising design teams on the quality and compliance implications of design decisions. Working with a high degree of autonomy, the Principal Quality Engineer influences Design Assurance strategy across programs, provides technical guidance and informal mentorship to engineers, and serves as a subject matter expert during regulatory interactions. The work emphasizes risk management, verification and validation oversight, design transfer, and practical execution to support timely, compliant product launches.

Requirements

Bachelor’s degree in Biomedical, Mechanical, or related Engineering discipline and 10 or more years of medical-device industry experience, or a Master’s degree and 8 or more years of experience.
Demonstrated progression providing technical leadership across multiple complex development programs.
Hands-on Design Verification and Validation experience, including review and approval of protocols and reports.
Test Method Validation experience, including development, execution, or quality oversight of validated methods.
Risk Management experience in accordance with ISO 14971 and experience developing and managing FMEAs.
Experience applying FDA GMP and ISO 13485 requirements in a design and development environment.
Ability to independently interpret and apply medical-device quality-system and regulatory requirements, 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 such as Minitab or equivalent.
Strong technical writing skills for quality documentation, including protocols, reports, and design history records.
Ability to manage multiple complex development activities while maintaining attention to detail and compliance.
Ability to act as a Principal-level technical authority, coach and informally mentor Senior and mid-level Quality Engineers, and influence cross-functional decisions.
Self-directed and accountable, with the ability to execute responsibilities independently and follow through on commitments.
Experience supporting regulatory inspections and audits (FDA, Notified Body, ISO), including preparation, participation, and response development.
Clear and effective communication skills for conveying technical and quality concepts to diverse audiences.
Willingness to travel up to 10% of the time.
Ability to lift objects up to 25 pounds.

Nice To Haves

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

Responsibilities

Lead quality assurance for new product development and partner with design teams to ensure compliance with ISO 13485 and applicable regulatory requirements.
Serve as a technical subject matter expert on regulatory standards, statistical methods, test design, and acceptance criteria.
Participate in design reviews, providing an independent perspective on compliance and risk.
Ensure Design History Files are complete, accurate, and inspection-ready throughout the development lifecycle.
Develop and maintain Risk Management Files, including plans and reports, hazard analyses, FMEAs, risk-control strategies, and risk assessments.
Support development and execution of incoming inspection plans, first article inspections, and related documentation aligned 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 activities; review and approve protocols, test methods, and reports.
Ensure V&V test strategies, acceptance criteria, and sample sizes are appropriate and compliant with applicable standards.
Advise on V&V activities including biocompatibility, sterilization validation, packaging validation, and shelf-life studies.
Lead or support test method validation activities and perform or witness hands-on Design V&V testing when needed.
Partner with 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 for new product development and design transfer.
Participate in FDA, Notified Body, and ISO 13485 audits and inspections.
Contribute to regulatory submissions, including 510(k), CE Technical Files, and PMA modules.
Apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions and perform additional duties as assigned.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the Company’s long-term incentive program.
Vacation: 120 hours per calendar year, subject to policy and hire date.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington, subject to policy and hire date.
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 a child’s birth, adoption, or foster-care placement.
Bereavement Leave: up to 240 hours for an immediate family member and 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.