Principal Quality Engineer - Johnson & Johnson MedTech, Circulatory Restoration (Shockwave Reducer)
Jj · New Brighton, Minnesota, United States
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.
Job Function:
Supply Chain Engineering
Job Sub Function:
Quality Engineering
Job Category:
Scientific/Technology
All Job Posting Locations:
New Brighton, Minnesota, United States of America
Job Description:
Johnson & Johnson is hiring for a Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business located in New Brighton, MN.
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 https://www.jnj.com/.
Cardiovascular Solutions from Johnson & Johnson
Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary and peripheral artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more information on circulatory restoration, visit our website.
Position Overview
The Principal 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 relate to design and development activities, advising design teams on the quality and compliance impacts of design decisions. Operating with a high degree of autonomy, the Principal Quality Engineer is expected to influence design assurance strategy across programs, provide mentoring and technical guidance to senior engineers, and serve as a subject matter expert during regulatory interactions. This role 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.
Essential Job Functions
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 to support new product development and design transfer
- Participate in FDA, Notified Body, and ISO 13485 audits/inspections
- Contribute to regulatory submissions (510(k), CE Technical Files, PMA modules)
- Understand and apply Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team
- Perform additional duties as assigned
Requirements
- Bachelor’s degree in Biomedical/ Mechanical, or related Engineering discipline with 10+ years of experience in the medical device industry, or Master’s degree with 8+ years of experience
- Demonstrated progression providing technical leadership across multiple complex development programs, including 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
- Demonstrated ability to independently interpret and apply applicable medical device quality system and regulatory requirements as they relate 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
- Acts as a Principal-level technical authority, providing coaching and informal mentorship to Senior and mid-level Quality Engineers and influencing cross-functional decision-making.
- 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