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

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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:

Minneapolis Minnesota United States of America New Brighton Minnesota United States of America Shoreview Minnesota United States of America St. Paul Minnesota United States

Job Description:

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 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 executionfocused 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 shelflife 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 & Johnsons Credo and Leadership Imperatives in day-to-day interactions with team.
• Perform additional duties as assigned contributing to team success.

Qualifications

Required Qualifications

Education & Experience:

• Degree in biomedical/mechanical engineering (or related field) bachelors with 5 years or masters 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

Regulatory & Technical Knowledge:

• Working knowledge of applicable medical device quality system and regulatory requirements as they apply to design and development activities including ISO 13485 ISOCFR 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

Core Competencies:

• 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

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
• Physical Requirements
  • Willingness to travel up to 10% of the time
  • Ability to lift objects up to 25 lbs

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 () or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning Coaching Customer Centricity Data Savvy Document Management Financial Competence Good Automated Manufacturing Practice (GAMP) Lean Supply Chain Management Process Improvements Quality Control (QC) Quality Services Quality Standards Quality Systems Documentation Quality Validation Science Technology Engineering and Math (STEM) Application Supervision Supply Planning Technologically Savvy

The anticipated base pay range for this position is :

$79000.00 - $127650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys 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: - Experience:

Senior IC