Santa Clara, California, United States of America, United States of America
Onsite
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Job Function:
Supply Chain ManufacturingJob Sub Function:
Robotics Service & RepairJob Category:
ProfessionalAll Job Posting Locations:
Santa Clara, California, United States of AmericaJob 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.
Key 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 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 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.
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.
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 Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Agile Manufacturing, Coaching, Computer Programming, Continuous Improvement, Critical Thinking, Good Manufacturing Practices (GMP), Industry Analysis, Innovation, Plant Operations, Predictive Analytics, Process Improvements, Project Reporting, Prototyping, Quality Assurance (QA), Repair Management, Robotic Automation, Service Request Management, Technical Credibility
The anticipated base pay range for this position is :
Salary Range $118,000 - $203,550 Bay Area OnlyAdditional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 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 Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefitsWant to know if this job is worth applying to?