Position Overview:
This person is responsible for supporting the engineering teams in creating comprehensive documentation for lab equipment. This role serves as the primary resource for engineering staff, offering guidance on tool management processes, documentation, and equipment procurement. Key responsibilities include organizing and maintaining equipment files within the Product Lifecycle Management (PLM) system, ensuring accuracy and completeness of Tool Change Orders (TCO) and maintenance records. The specialist collaborates with QA and Design Control teams to ensure equipment compliance with regulatory and quality standards, assisting with equipment requirements and validation assessments.
Responsibilities:
Create comprehensive documentation for equipment used by R&D teams, including user manuals, technical specifications, and safety guidelines
Serve as the go-to resource for engineering staff, providing guidance on tool management processes, documentation, and equipment procurement
Organize and maintain equipment files within the PLM system for existing equipment. Ensure accuracy and completeness by revising existing equipment files, including TCO and maintenance records.
Collaborate with QA and Design Control to ensure equipment compliance with regulatory and quality standards assisting with equipment requirements and validation assessments
Maintain an accurate inventory of tools and equipment, tracking their availability, location, and condition
Oversee the equipment tracking system, ensuring timely updates and data integrity
Monitor equipment utilization and identify opportunities for optimization or replacement
Coordinate equipment training sessions for users, ensuring proper usage and safety protocols
Performs or supports execution of small repairs as directed
Performs other duties as necessary
Education and Experience:
High School Diploma / GED and 6+ years working in a laboratory environment, or Associates and 4+ years
Skills/Competencies:
Self-starter, detail-oriented, and effective verbal/written communicator
Ethical, responsible, and data-driven decision-making methodology
Ability to organize work and judge priorities with guidance
Experience creating technical documentation for complex equipment
Familiarity with PLM systems (ex. Arena) and document management
Knowledge of validation processes and regulatory requirements
Experienced with building relationships with engineering staff and vendors
Working knowledge of Enterprise Asset Management software (ex. SAP)
Experienced with GDP (accurate recordkeeping)
Understanding of procurement and inventory control
Office software proficiency (Word, Excel) and technical writing capabilities
Experience in a medical device regulated environment
Able to lift 20 lbs
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from our Acton, MA office; may work remotely other days).
Additional Information:
Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $22.97 - $34.45 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.
We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.