Manager, Equipment Calibration

Company Overview

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview

Insulet's Plant Engineering organization is looking for a Calibration Manager to provide the leadership and technical expertise overseeing the maintenance and operation calibration equipment and systems.  Responsible for ensuring that all measuring instruments and equipment are accurate and compliant with industry standards and regulations. 

The Manager, Calibration is a key member of the Plant Engineering's leadership team, reporting to the Director of US Plant Engineering, and is responsible for the design and implementation of the resources, processes and systems

Responsibilities

• Manage the equipment maintenance and calibration programs for the Global Manufacturing Department
• Manage and mentor direct reports within the equipment maintenance and calibration function
• Supervise and lead the calibration team, including scheduling, training, and performance management.
• Establish and maintain company compliance to ISO 13485, 21 CFR 820, MDSAP and related standards, regulations, and requirements for the equipment maintenance and calibration programs

• Develop and manage the calibration program including budget, procedures, master data, frequencies, and tolerances utilizing risk assessments and good calibration practices
• Training and supervising calibration technicians to ensure they follow the correct procedures and maintain accurate records.
•  Develop and monitor KPIs related to calibration performance and compliance.

• Develop and implement metrics to measure calibration program execution including budget, trends, and out of tolerance (OOT) conditions

• Deploy and manage System Analysis Program (SAP) for equipment maintenance and calibration
• Develop, implement, and maintain the calibration program for all M&TE.
• Planning and scheduling the calibration of measuring and test equipment
• Training and supervising calibration technicians to ensure they follow the correct procedures and maintain accurate records.
• Maintain calibration records and documentation in accordance with regulatory and audit requirements.
• Coordinate with internal departments and external vendors for calibration services.
• Analyze calibration data and trends to identify areas for improvement.
• Manage calibration lab equipment, tools, and software systems.
• Support audits and inspections by providing calibration documentation and expertise.

Required Skills and Competencies

• Proven experience as a Calibration Manager or similar role
• In-depth knowledge of calibration standards and procedures
• Excellent leadership and team management skills
• Strong problem-solving abilities
• Attention to detail and accuracy
• Ability to work under pressure and meet deadlines
• Strong communication and interpersonal skills
• Certification from a recognized calibration institute is a plus
• Experience working in clean room or GMP environments.

Preferred Skills and Competencies

• Ability to interpret technical drawings, specifications and standards.
• Proficiency in SAP.
• Certification in metrology or calibration (e.g., ASQ CCT, CMI).
• Familiarity with Lean, Six Sigma, or other continuous improvement methodologies.

Education and Experience

• Bachelor’s degree (or equivalent experience)
• 8+ years of experience in calibration, metrology, or a related quality role
• 3+ years of management/leadership experience

Additional Information

• The position is located at our Acton, MA office.
• Less than 15% of travel is estimated but will flex depending on business need.

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