Johnson & Johnson MedTech · 8 hours ago
Sr Electronics Production Engineer
Danvers, MA
Full-time
Onsite
Mid, Senior Level
$94K/yr - $152K/yr
6+ years expJohnson & Johnson MedTech is dedicated to healthcare innovation, aiming to improve treatment options for complex diseases. The Sr Electronics Production Engineer will drive the scale-up and production of electro-mechanical medical devices, ensuring compliance with safety regulations and leading continuous process improvements.
Hospital & Health Care
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
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 MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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