Manager, Tool and Test Equipment - Service

Johnson & Johnson • Santa Clara, CA

11d • Onsite

About The Position

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.

Requirements

• 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 skills.

Nice To Haves

• Knowledge of service processes for medical devices.
• Experience specifying, qualifying, and validating measurement and test tools.
• Familiarity with technical standards such as IEC 62353, IEC 60601, and ISO 14971.
• Strong background in statistical process control and risk-based decision making.
• Experience with ERP integration and digital document control systems.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• Forecast tooling and equipment obsolescence and develop mitigation strategies.
• Manage retirement, documentation updates, and traceability controls for decommissioned tools.
• 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.
• 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.

Benefits

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• Vacation –120 hours per calendar year
• Sick time - 40 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
• Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed