Quality Systems PLM Business Analyst (Hybrid - Acton, MA)

Position Overview:

The Quality Systems PLM Business Analyst will play a key role in supporting and enhancing Insulet’s Product Lifecycle Management (PLM) systems. This individual will collaborate with cross-functional teams to gather business requirements, analyze workflows, and implement system improvements. The role includes light configuration of PLM tools, ongoing system maintenance, and user support to ensure optimal performance and compliance with quality standards.

Responsibilities:

• Partner with business stakeholders to identify and document PLM enhancement opportunities.
• Translate business needs into functional requirements and user stories for PLM system improvements.
• Perform light configuration and setup within Arena PLM or other platforms, including workflows, fields, and user roles.
• Support PLM system maintenance activities such as user provisioning, data integrity checks, and release testing.
• Assist in the validation of PLM system changes, including test script development and execution.
• Monitor system performance and user feedback to identify areas for continuous improvement.
• Collaborate with IT and Quality teams to ensure PLM changes align with QMS and regulatory requirements.
• Participate in cross-functional meetings and projects related to PLM, document control, and change management.
• Maintain documentation related to PLM configurations, enhancements, and training materials.

Education And Experience:

Minimum Requirements:

• Typically requires a four-year degree from an accredited University or a combination of education and relevant work experience.
• 3+ years of experience in PLM systems (Arena, Oracle Cloud, Agile, etc.) within a regulated industry.
• Strong understanding of Quality Management Systems (QMS), including change control and document control processes.
• Experience with system configuration, user support, and business analysis in a PLM environment.
• Familiarity with GxP, ISO 13485, 21 CFR Part 820, and other relevant standards.
• Excellent communication and collaboration skills across technical and non-technical teams.
• Proficiency in Microsoft Office and experience with tools like Jira, ServiceNow, or similar platforms is a plus.

Preferred Skills And Competencies:

• Experience with Arena PLM configuration and integration projects.
• Exposure to data mapping and system integration (e.g., Arena to SAP).
• Ability to manage multiple priorities and deliver in a fast-paced environment
• Experience in implementing or enhancing electronic PLM and/or EQMS systems.
• Effective verbal and written communication skills.
• Ability to communicate at multiple levels of an organization.
• Ability to manage, organize tasks and judge priorities.

Physical Requirements (If Applicable):

• Domestic and International travel up to 10%. 

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid

Additional Information:

The US base salary range for this full-time position is $72,000.00 - $108,000.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

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.

(Know Your Rights)