Principal Quality Engineer - Johnson & Johnson MedTech, Circulatory Restoration (Shockwave Reducer)

Description

The team is building medical devices for cardiovascular care, including circulatory restoration, heart rhythm and neurovascular products. This role supports the Shockwave Reducer business in New Brighton, Minnesota.

The role ensures devices are designed, developed and handed over to manufacturing in line with quality system and regulatory requirements. You will work with R&D, Manufacturing, Regulatory Affairs, Clinical Affairs and Marketing throughout new product development, applying medical device standards to design choices and advising teams on their quality and compliance effects. You will work largely on your own, shape design assurance strategy across programs, mentor senior engineers and speak for quality in regulatory discussions. The focus is hands-on, practical quality work on risk management, verification and validation oversight and design transfer, so launches stay on schedule and compliant.

Responsibilities

• Lead quality assurance for new product development.
• Work with design teams to meet ISO 13485 and other applicable regulations.
• Act as the technical expert on standards, statistics, test design and acceptance criteria.
• Join design reviews and give an independent view on compliance and risk.
• Keep Design History Files complete, accurate and ready for inspection across the development lifecycle.
• Build and maintain Risk Management Files, including plans, reports, hazard analyses, FMEAs, risk controls and risk assessments.
• Support incoming inspection plans, first article inspections and related records so they match design intent.
• Advise design teams on the quality system and regulatory impact of design decisions and changes.
• Oversee design assurance for verification and validation, including biocompatibility, sterilization, packaging and shelf-life studies.
• Review and approve protocols, test methods and reports.
• Check that test strategies, acceptance criteria and sample sizes are suitable and meet applicable standards.
• Lead or support test method validation so methods suit their intended use and meet internal and regulatory expectations.
• Perform or witness design verification and validation testing when needed for design assurance.
• Work with Manufacturing and Operations on design transfer and validation.
• Support equipment and process validation (IQ/OQ/PQ) for new product introductions.
• Confirm manufacturing processes, controls and validations match design intent and regulatory requirements.
• Support Contract Manufacturing and Supplier Quality in finding, qualifying and managing suppliers for new products and design transfer.
• Take part in FDA, Notified Body and ISO 13485 audits and inspections.
• Contribute quality content to regulatory submissions such as 510(k), CE Technical Files and PMA modules.
• Apply the company's Credo and Leadership Imperatives in daily work with the team.
• Take on other duties as assigned.

Requirements

• A bachelor's degree in biomedical, mechanical or a related engineering field with 10+ years in the medical device industry, or a master's degree with 8+ years in the industry.
• A record of technical leadership across several complex development programs, with hands-on work in design verification and validation, including reviewing and approving protocols and reports.
• Experience in test method validation, including developing, running or overseeing quality for validated methods.
• Experience applying ISO 14971 risk management and developing and managing FMEAs.
• Experience applying FDA GMP and ISO 13485 in a design and development setting.
• Ability to independently interpret and apply quality system and regulatory requirements for design and development, including ISO 13485, ISO 14971, 21 CFR Part 820 / FDA QMSR and EU MDR (2017/745).
• Strong statistics and analysis skills, including hypothesis testing, sample size determination and data analysis, plus proficiency in statistical software such as Minitab or equivalent.
• Strong technical writing for quality documents, including protocols, reports and design history records.
• Ability to manage several complex development activities at once with close attention to detail and compliance.
• Principal-level technical authority who coaches and informally mentors senior and mid-level quality engineers and shapes cross-functional decisions.
• Self-directed and accountable, able to carry out assigned work and follow through on commitments.
• Experience supporting regulatory inspections and audits (FDA, Notified Body, ISO) through preparation, participation and response writing.
• Clear communicator who can explain technical and quality concepts to varied audiences.
• Willingness to travel up to 10% of the time.
• Ability to lift up to 25 lbs.

Conditions

Based in New Brighton, Minnesota, United States of America.

Anticipated base pay is $102,000.00 to $177,100.00.

Eligible for the company's long-term incentive program.

Eligible for the consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.

Time off, subject to policy and hire date: 120 hours vacation per calendar year; 13 days holiday pay including floating holidays per calendar year; 40 hours sick time per calendar year (48 hours in Colorado, 56 hours in Washington); up to 40 hours work, personal and family time per calendar year.

The company is an equal opportunity employer that values diversity and does not discriminate.

Benefits

• Parental leave of 480 hours within one year of the birth, adoption or foster care of a child.
• Bereavement leave of 240 hours for an immediate family member, or 40 hours for an extended family member, per calendar year.
• Caregiver leave of 80 hours in a 52-week rolling period.
• Volunteer leave of 32 hours per calendar year.
• Military spouse time off of 80 hours per calendar year.
• Further benefits details are available on the company's careers site.