Manager, Tool and Test Equipment - Service

Responsibilities

• Tool & Equipment Lifecycle Management
• Lead risk-based selection and justification of measurement and test equipment.
• Review technical documentation and regulatory requirements to determine measurement precision, tolerances, and traceability.
• Maintain a master equipment register and oversee SOPs related to tool selection and qualification.
• Supplier & Calibration House Management
• Develop and manage supplier evaluation and qualification programs in accordance with ISO and FDA purchasing controls.
• Audit and manage relationships with OEMs, calibration houses, and distributors.
• Oversee contract negotiations, service-level agreements, performance scorecards, and corrective action management.
• Calibration Program Oversight
• Develop a risk-based calibration schedule aligned with regulatory and OEM requirements.
• Utilize digital calibration management or CMMS systems for automated tracking and recordkeeping.
• Ensure adherence to labeling, scheduling, and documentation requirements.
• Out-of-Tolerance (OOT) Investigations
• Quarantine and assess the impact of OOT equipment on product or service performance.
• Lead root-cause investigations and coordinate CAPA actions.
• Ensure thorough regulatory documentation and audit readiness.
• Obsolescence Planning & Decommissioning
• Forecast tooling and equipment obsolescence and develop mitigation strategies.
• Manage retirement, documentation updates, and traceability controls for decommissioned tools.
• Data Analytics & Continuous Improvement
• Provide organizational expertise in:
• OOT investigation trends
• Mean Time Between Failures (MTBF)
• Predictive maintenance strategies
• System and tool capability (CpK)
• Service performance metrics
• Drive continuous improvement through data-driven insights.
• Regulatory & Quality System Compliance
• Develop, maintain, and enforce SOPs, work instructions, and records related to equipment control.
• Serve as the audit liaison for test equipment management during MDSAP, FDA, and notified body audits.
• Maintain regulatory surveillance and update policies in accordance with evolving standards.
• Required Experience & Qualifications
• Extensive experience managing test equipment and calibration programs in a regulated medical device environment.
• Demonstrated project management capability, including planning, executing, and delivering multi‑phase tool and equipment initiatives on time and within scope.
• Proven experience supporting regulatory inspections and leading audit walkthroughs.
• Strong understanding of metrology concepts, equipment tolerances, uncertainty, and traceability.
• Proficiency with electronic calibration management tools (e.g., SimplerQMS, Blue Mountain, MasterControl).
• Advanced capability in data analysis using Power BI.
• Strong organizational skills, attention to detail, and SOP documentation experience.
• Effective communicator with cross-functional collaboration

Benefits

Additional Information

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Manufacturing Job Sub Function: Robotics Service & Repair Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson MedTech is currently recruiting for a Manager, Tool and Test Equipment. This role is based in Santa Clara, CA. ABOUT MEDTECH Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Position Summary The Manager, Tool & Test Equipment is a strategic and operational leader responsible for the full lifecycle management of all tools and test equipment within a medical device service environment. This role ensures all equipment is selected, procured, calibrated, maintained, analyzed, and decommissioned in compliance with ISO 13485, ISO 9001, MDSAP, EU MDR, and FDA 21 CFR Part 820 requirements. This position sits at the intersection of engineering, quality, supply chain, and compliance-supporting field service and manufacturing teams to deliver safe, accurate, efficient, and fully compliant medical device services.

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