Sr Engineer, Manufacturing Systems
About The Position
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
Requirements
- B.S. degree in Engineering, Computer Science, Information Systems, or equivalent
- 7+ years of experience in manufacturing systems, automation/IT for manufacturing, or process engineering with strong exposure to shop-floor operations
- Hands-on experience implementing and supporting Siemens Opcenter (or comparable MES) and integrating MES with ERP and shop-floor systems (e.g., SAP, equipment interfaces, label/UDI systems)
- Experience in medical device manufacturing and familiarity with QMS and compliance expectations (e.g., ISO 13485, FDA 21 CFR Part 11, GDP/GMP) including data integrity and audit readiness
- Strong problem-solving and root-cause analysis skills; comfortable working under time pressure in a production environment
- Excellent communication and stakeholder management skills; able to lead discussions, influence decisions, and drive execution across functions
Responsibilities
- Provide onsite support for Opcenter-enabled production operations; troubleshoot issues, restore service quickly, and coordinate escalations with IT and vendors as needed
- Lead and coordinate cross-functional workshops to define requirements, map current/future state processes, and align implementation plans and validation strategy
- Own change control for manufacturing system and process changes in alignment with the Quality Management System (QMS): impact assessment, risk evaluation, documentation, testing, approvals, deployment, and communication to maintain a validated state
- Design, configure, and improve Opcenter MES capabilities (e.g., routings/operations, electronic work instructions, data collection, equipment/line modeling, genealogy/traceability, electronic records) to support production execution and Device History Record/electronic batch record needs, including UDI-related data where applicable
- Plan and execute testing (unit/integration/UAT) and support computer system validation activities (e.g., URS/FRS, traceability, IQ/OQ/PQ, Part 11 assessment) and data integrity controls in partnership with Quality and IT
- Drive continuous improvement by analyzing production and quality data (e.g., yield, scrap, nonconformances) to identify defects, bottlenecks, and opportunities for standardization and error-proofing within Opcenter workflows
- Develop and maintain controlled SOPs/work instructions, training materials, and a sustainable support model (key-user network, knowledge base, release playbooks, metrics) for shop-floor and support teams
Benefits
- medical
- dental
- vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- consolidated retirement plan (pension)
- savings plan (401k)
- long-term incentive program
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
