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Johnson & Johnson · 1 month ago

Principal Production Engineer

Danvers, Massachusetts, United States of America

Full-time

Onsite

Senior Level, Lead/Staff

$100K/yr - $172K/yr

10+ years exp

Johnson & Johnson is a leader in healthcare innovation, focused on developing advanced medical solutions. The Principal Production Engineer will provide strategic and hands-on technical leadership across manufacturing operations for complex electro-mechanical medical devices, ensuring regulatory compliance and driving continuous improvement initiatives.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Define and drive the manufacturing strategy and technology roadmap for scale-up, capital projects, and process automation

Lead critical programs from concept through commercialization, ensuring alignment with regulatory, quality, and business goals

Own scale-up from pilot/early production to full-scale manufacturing; manage design transfer activities with cross-functional teams

Develop robust manufacturing readiness plans, including process mapping, equipment qualification, and line layout optimization

Lead IQ/OQ/PQ strategies for equipment, processes, packaging, and software where applicable

Develop validation protocols, execute plans, analyze results, and secure sign-off; ensure traceability to user needs and regulatory requirements

Champion structured problem solving for yield issues, quality escapes, and process deviations

Drive CAPA execution, verify effectiveness, and close with data-backed evidence and sustainability

Maintain alignment with regulatory expectations (e.g., FDA QSR/21 CFR Part 820, ISO 13485) and support regulatory submissions as needed

Lead Lean/Six Sigma initiatives to improve throughput, reduce cycle times, increase yield, and lower cost per unit

Apply DOE, SPC, MSA, Cp/Cpk analyses and other advanced analytics to optimize processes and sustain gains

Define and track KPIs (yield, scrap rate, OEE, CAPA closure, cycle time) and provide actionable insights to leadership

Develop dashboards and storytelling visuals to communicate program status and risks

Partner with Quality, Regulatory, R&D, Supply Chain, and Operations to align on milestones, risks, and resource needs

Mentor and coach engineers and technicians; foster a culture of continuous improvement and knowledge sharing

Qualification

Manufacturing EngineeringFDA QSR/21 CFR Part 820ISO 13485Process ValidationLean Manufacturing PrinciplesDesign TransferDOECAPA ManagementCoachingSafety-OrientedCritical ThinkingProject Management

Required

Bachelor's degree in Mechanical, Industrial, Biomedical, or related Engineering; Master's degree or equivalent experience preferred

10+ years in manufacturing engineering or operations within medical devices or complex product environments

Deep understanding of FDA QSR/21 CFR Part 820 and ISO 13485

Experience with design controls, design transfer, validation activities, and quality systems in a regulated setting

Proficient in DOE, SPC, MSA, Cp/Cpk, PFMEA, Control Plans, and CAPA management

Knowledge of manufacturing processes (e.g., plastics, polymers, adhesives, molding, assembly, packaging, sterilization) as relevant to the product line

Experience with change control, CAPA, PFMEA, control plans, and documentation management

Excellent problem-solving, communication, and project-management skills

Demonstrated ability to lead large-scale programs and mentor diverse teams

Preferred

Benchmarking

Coaching

Critical Thinking

Facility Management

Leading Change

Lean Manufacturing Principles

Lean Supply Chain Management

Manufacturing Engineering

Manufacturing Flow Management

Organizing

Performance Measurement

Predictive Maintenance

Product Design

Program Management

Project Schedule

Safety-Oriented

Science, Technology, Engineering, and Math (STEM) Application

Strategic Thinking

Benefits

Medical

Dental

Vision

Life insurance

Short- and long-term disability

Business accident insurance

Group legal insurance

Company’s consolidated retirement plan (pension)

Savings plan (401(k))

Company’s long-term incentive program

Vacation –120 hours per calendar year

Sick time - 40 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

Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member

Caregiver Leave – 10 days

Volunteer Leave – 4 days

Military Spouse Time-Off – 80 hours

Company

Johnson & Johnson

Glassdoor4.2

At Johnson & Johnson, we believe health is everything.

Founded in 1886

New Brunswick, NJ, US

10001+ employees

http://www.jnj.com

H1B Sponsorship

Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)