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Johnson & Johnson · 1 month ago

Sr Electronics Production Engineer

Danvers, Massachusetts, United States of America

Full-time

Onsite

Mid, Senior Level

$94K/yr - $152K/yr

6+ years exp

Johnson & Johnson is a leader in healthcare innovation, committed to developing advanced medical solutions. The Sr. Electronics Production Engineer will drive the scale-up and production of electro-mechanical medical devices, ensuring compliance with safety and regulatory standards while focusing on process improvement and cost savings.

Hospital & Health Care

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Lead scale-up from pilot to full-scale production, including process development, equipment qualification, line layout, and work instructions

Collaborate with R&D and Quality to ensure smooth design transfers and robust manufacturing readiness

Plan and execute IQ/OQ/PQ activities for equipment, processes, and software where applicable

Develop and approve validation protocols and reports; ensure traceability to user needs and regulatory requirements

Lead root-cause analysis for yield loss, quality escapes, and process deviations using structured problem-solving methods

Implement corrective and preventive actions (CAPA), verify effectiveness, and close with data-driven evidence

Ensure manufacturing activities comply with EHS standards and device safety requirements

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

Identify and execute Lean/Six Sigma projects to improve throughput, reduce cycle times, increase yield, and lower cost per unit

Apply statistical methods (DOE, SPC, MSA, Cp/Cpk analysis) to optimize processes and sustain gains

Maintain and improve documentation: SOPs, work instructions, MBR/Device History Records, change controls, and validation artifacts

Develop and manage PFMEA, Control Plans, and ongoing quality checks to ensure product reliability

Provide hands-on troubleshooting on the manufacturing floor; drive standard work, line balancing, and equipment optimization

Monitor key production metrics and implement actions to meet targets for quality, cost, and schedule

Partner with Quality, Regulatory, Supply Chain, Manufacturing, and R&D to align on program milestones, risk, and resource needs

Mentor and coach junior engineers and technicians; contribute to a culture of continuous improvement

Qualification

Manufacturing EngineeringProcess ValidationFDA QSR/21 CFR Part 820ISO 13485Statistical Process ControlRoot Cause AnalysisLean Manufacturing PrinciplesElectronics AssemblyProject ManagementCommunication SkillsProblem-Solving SkillsCross-Functional Collaboration

Required

Bachelor's degree in Engineering (Electrical, Mechanical, Biomedical, Industrial, or related). Master's degree strongly preferred

6–10+ years of manufacturing engineering experience in electronics or medical devices (device hardware, electronics assembly, or related fields)

Working knowledge of FDA QSR/21 CFR Part 820 and ISO 13485. Experience supporting or leading design transfers, validation activities, and quality systems in a regulated environment

Proficient in DOE/DOE-based experiments, statistical process control (SPC), capability analyses (Cp/Cpk), MSA, and root-cause analysis methodologies

Experience with process validation (IQ/OQ/PQ) and risk-based approaches to manufacturing

Familiarity with PCB/SMT assembly, soldering, testing, electronics packaging, and related manufacturing processes

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

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

Ability to work cross-functionally, influence without authority, and manage multiple priorities in a fast-paced environment

Preferred

Accelerating

Coaching

Critical Thinking

Facility Management

Good Manufacturing Practices (GMP)

Lean Manufacturing Principles

Lean Supply Chain Management

Manufacturing Engineering

Performance Measurement

Product Design

Program Management

Project Engineering

Project Schedule

Risk Compliance

Robotic Automation

Safety-Oriented

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

Technologically Savvy

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

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

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Trends of Total Sponsorships

2025 (48)

2024 (56)

2023 (58)

2022 (59)

2021 (44)

2020 (27)