Sr Electronics Production Engineer

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:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Sr. Electronics Production Engineer

Purpose: This role will drive the scale-up and production of a complex electro-mechanical medical device used in life-saving cardiac support therapies. This role will own scale-up activities, validations, root-cause investigations, safety and regulatory compliance, and continuous process improvement with a focus on cost savings and robust, repeatable manufacturing processes.

You will be responsible for:

• Scale-Up & Design Transfer

• • 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.

• Validation & Verification

• • 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.

• Root Cause Investigation & CAPA

• • 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.

• Safety & Regulatory Compliance

• • 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.

• Process Improvement & Cost Savings

• • 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.

• Quality Systems & Documentation

• • 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.

• Production Support

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

  • Monitor key production metrics and impl