Position Overview
Johnson & Johnson is hiring for a Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business located in New Brighton, MN.
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 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
Other
•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
•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
Preferred Qualifications
•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
Compensation
The anticipated base pay range for this position is $102,000.00 - $177,100.00. Employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)), and the Company's long-term incentive program. Time off benefits include: Vacation – 120 hours per calendar year; Sick time – 40 hours per calendar year (48 hours in Colorado, 56 hours in Washington); 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 birth/adoption/foster care of a child; Bereavement Leave – 240 hours for immediate family, 40 hours for extended family 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.
