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New Brighton, Minnesota, United States of America, United States of America
Hybrid
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Job Function:
Supply Chain EngineeringJob Sub Function:
Quality EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
New Brighton, Minnesota, United States of AmericaJob Description:
Johnson & Johnson is hiring for a Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business 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
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.
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
Bachelor’s degree in Biomedical/Mechanical or related Engineering discipline with 10+ years of experience in the medical device industry, or a 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
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
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
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Coaching, Controls Compliance, Critical Thinking, Engineering, Fact-Based Decision Making, Financial Competence, ISO 9001, Lean Supply Chain Management, Non-Conformance Reporting (NCR), Organizing, Process Improvements, Quality Control Testing, Quality Standards, Quality Systems Documentation, Quality Validation, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application
The anticipated base pay range for this position is :
$102,000.00 - $177,100.00Additional Description for Pay Transparency:
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)).