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

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 Quality Engineer II to join our Shockwave Reducer team 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/.

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 (SWMI-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.

Position Overview:
The Quality Engineer II (QE II) will have direct responsibilities related to the establishment and qualification of the SWMI-MN facility. This includes development, implementation, and maintenance of SWMI-MN procedures and processes. In addition, the QE II supports development, manufacturing, and post-production activities and works cross-functionally to resolve technical problems. This QE II participates in strategic decisions regarding project scope, risk management, design updates, process optimization, and material disposition. Responsibilities may include test method development/validation, root cause/failure analysis, and post-market surveillance including complaint investigations and complaint monitoring/trending. The ideal candidate will offer innovative solutions and support the successful execution of quality engineering activities across the facility and product lifecycle.

Essential Job Functions:

• Develop, apply, and maintain robust quality standards for materials, components, and products, ensuring full alignment with regulatory and company requirements.

• Design and implement advanced methods and procedures for inspection, testing, and evaluation to assess the precision and accuracy of products, sub-assemblies, and production equipment.

• Prepare comprehensive documentation, including inspection/testing procedures, validation protocols, quality plans, and product defect investigations. Ensure technical documents are clear, accurate, and meet regulatory requirements. Review and provide feedback on technical documents from peers.

• Independently evaluate whether products meet specifications and initiate corrective actions for non- conformances in collaboration with cross-functional teams.

• Collaborate with manufacturing and development engineers to establish and enhance process controls, optimize documentation, and drive continuous improvement through data-driven insights.

• Drive continuous improvement initiatives using tools such as Lean, Six Sigma, or similar methodologies to optimize processes, reduce defects, and improve overall product quality.

• Take ownership of complex tasks, performing them with minimal supervision while managing technical complexity and making key decisions, seeking guidance only for non-routine challenges.

• Lead detailed phases of engineering work within projects, ensuring timelines and goals are met.

• Provide leadership in risk management efforts in product development, including conducting FMEA, risk assessments, and failure mode evaluations to ensure device safety and compliance.

• Collaborate closely with regulatory affairs and compliance teams to ensure the timely preparation andsubmission of regulatory filings, as well as compliance with global regulations.

• Address complex challenges such as conflicting design requirements or material incompatibility, leveraging broad engineering knowledge and precedent.

• Apply knowledge of FDA guidance, ISO, and ASTM standards to ensure compliance with relevant regulations.

• Ensure adherence to Health, Safety, and Environmental compliance standards, following Federal, State, and local regulations.

• Conduct internal and supplier audits to ensure compliance with ISO13485: 2016 and other relevant standards. Lead Auditor certification is a plus.

• Investigate customer complaints and provide comprehensive technical reports based on device performance and investigation data. Communicate findings with customers when necessary.

• Maintain calibration standards for tools and equipment used across R& D, Manufacturing, and Quality areas.

• Utilize statistical tools such as Minitab for process capability assessments, data analysis (normality, variance), hypothesis testing, sample size determination, design of experiments (DOE), and application of sampling plans.

• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

• Perform additional duties as assigned, contributing to team success.

Requirements

Education/Certifications:

• Bachelor’s degree in a related engineering discipline with 2+ years of medical device industry experience; OR

• Master’s degree in a related engineering discipline.

• Quality Engineer (CQE), Six Sigma, and Lead Auditor Certification is a plus.

Regulatory/Compliance Knowledge:

• Working knowledge of medical device regulations (e.g., ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP).

Technical Skills:

• Strong technical writing skills, with the ability to create clear, accurate, and regulatory-compliant documents.

• Experience in customer complaint investigations, failure analysis, and complaint report writing is a plus.

• Proven ability to provide manufacturing support in a Quality Engineering capacity.

• Familiarity with balloon catheter technology is a strong plus.

Experience:

• Design Verification and Validation (DV& V) protocol writing and review experience.

• Experience generating documentation for manufacturing line transfers and site validations is highly preferred.

• Experience in leading or participating in continuous improvement initiatives using methodologies such as Lean, Six Sigma, or similar, to optimize processes and reduce defects.

• Experience using Product Lifecycle Management (PLM) and Manufacturing Execution Systems (MES) to oversee the full development lifecycle and manufacturing processes of medical devices, ensuring traceability, compliance, and efficient workflows.

Work Style:

• Proactive and self-motivated, with the ability to work independently and manage complex tasks with minimal supervision.

• Able to manage multiple priorities in a fast-paced, dynamic environment and adjust to evolving requirements.

• Strong communication skills with the ability to effectively collaborate with all levels of management and teams.

Other Requirements:

• Willingness to travel up to 10% of the time.

• Ability to lift objects up to 25lbs.

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.

The anticipated base pay range for this position is:

$63, 000 - $102, 350

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http: //www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.