Manager, Tool and Test Equipment - Service

Johnson & Johnson MedTech is focused on innovation at the intersection of biology and technology, developing next‑generation treatments to improve patient wellness. We are recruiting for a Manager, Tool and Test Equipment located in Santa Clara, CA. Position Summary The Manager, Tool & Test Equipment is a strategic leader responsible for the full lifecycle management of all tools and test equipment within a medical device service environment. The role ensures tools are selected, procured, calibrated, maintained, analyzed, and decommissioned in compliance with ISO 13485, ISO 9001, MDSAP, EU MDR, and FDA 21 CFR Part820. This position operates 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. Key Responsibilities Tool & Equipment Lifecycle Management Lead risk‑based selection and justification of measurement and test equipment. Review technical documentation and regulatory requirements to define 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 record‑keeping. 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 expertise in OOT investigation trends, MTBF, predictive maintenance strategies, CpK, and 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 such as SimplerQMS, Blue Mountain, or MasterControl. Advanced capability in data analysis using PowerBI. Strong organizational skills, attention to detail, and SOP documentation experience. Effective communicator with cross‑functional collaboration skills. Preferred Skills Knowledge of service processes for medical devices. Experience specifying, qualifying, and validating measurement and test tools. Familiarity with technical standards such as IEC62353, IEC60601, and ISO14971. Strong background in statistical process control and risk‑based decision making. Experience with ERP integration and digital document control systems. Agile Manufacturing, Coaching, Computer Programming, Continuous Improvement, Critical Thinking, Good Manufacturing Practices (GMP), Innovation, Plant Operations, Predictive Analytics, Process Improvements, Project Reporting, Prototyping, Quality Assurance (QA), Repair Management, Robotic Automation, Service Request Management, Technical Credibility. Why Join Us Impact patient safety and device reliability across global service operations. Lead a critical compliance function with visibility across engineering, quality, and service teams. Drive innovation in data analytics, tooling strategy, and operational excellence. Compensation & Benefits Salary Range: $118,000 – $203,550 (Bay Area) Benefits include medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, and group legal insurance. Employees are eligible for the company’s consolidated retirement plan (401(k)) and receive vacation (120hours per calendar year), sick time (40hours per calendar year), holiday pay (13days per calendar year), and various leave options such as parental leave, military spouse time‑off, and more. Detailed benefit information is available at Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section503 of the Rehabilitation Act. Disability Accommodations We are committed to providing an inclusive interview process. If you are an individual with a disability and would like to request an accommodation, please contact us at or, for internal employees, ask AskGS to direct you to your accommodation resource. #J-18808-Ljbffr 6267-Auris Health Inc. Legal Entity