Manager, Global Vigilance Writing (Hybrid - Acton, MA)

Job Summary The Manager, Global Vigilance Writing is a hands-on technical leader serving as a post-market vigilance (reportable event) and surveillance subject matter expert and representative to improve awareness, visibility, and communication on quality/compliance initiatives supporting post-market vigilance. This role will provide direction to individuals who are responsible for the assessment, follow-up, coding, and vigilance activities for complaints determined to be reportable for the US FDA and other countries. The role requires strong organization skills and attention to detail while working in cross functional teams to accomplish departmental and company goals.

Job Title:

Engineering Manager, Post Market Investigation Lab Department:

8610 -

QA Post Market Quality Assurance FLSA Status:

Exempt Position Overview:

This position is an integral part of Insulet's Post Market Surveillance Department. It requires leadership, organization, process knowledge, and attention to detail while working with other QA/RA functions to ensure compliance and the accomplishment of departmental and company goals. This position is responsible for the management of a complaint lab team (consisting of Post Market Engineering Team Leads, Failure Analysis Engineers, Associate Failure Analysis engineers, Quality Technicians & Quality Associates) that process all investigations from initiation to closure.

Responsibilities:

Monitor complaint lab activity to ensure timely complaint resolution that meets or exceeds departmental, customer and regulatory requirements.

Approve / Sign

-off work evaluations from complaint lab team. Technical expert responsible for providing feedback and training concerning write-ups and approvals to drive team improvement. Utilize superior leadership to model, reward, and enforce behaviors that support Insulet's culture. Supervise, mentor, and provide work direction to the complaint lab team. Drive performance and establish Key Performance Indicators (KPIs) to achieve organizational goals for complaint rate, daily throughput, and efficient staff utilization. Works closely with appropriate personnel in R D, Operations, and Quality Assurance to further analyze investigation results to determine root cause to mitigate and/or eliminate future complaints or customer dissatisfaction. Promote and instill a culture of continuous improvement through standard improvement principles and practices (i.e. line balancing, value stream mapping, pareto analysis, etc.). Establish work planning to include development and maintenance of a plan incorporating hiring, training, efficiencies, etc. Must adhere to all regulatory requirements for complaint handling including the FDA and any other competent authority as required. Effectively write responses to competent authorities upon their request for more information. Purchase appropriate consumables for the continued operation of the complaint Lab. Direct the training efforts on evaluations and procedural changes. Performs other duties as assigned.

Education and Experience:

Minimum Requirements:

BS/BA degree in engineering Demonstrated people management experience leading teams of 5 or more technical employees.

Preferred Skills and Competencies:

Proven leadership skills to engage, coach, mentor, and develop the team, inspire high quality and timely work. 8+ years of experience in the field with 5 or more years of related experience in medical device complaint processes. 3-5 years of people manager / supervisory experience. Knowledge of Regulatory and Quality Management skills. Effective verbal and excellent technical writing skills. Ability to communicate and work effectively within the organization. Ability to organize and follow through with tasks with minimal supervision. Lead individuals in the process compliance needs of the organization. Excels at generating and maintaining organized and accurate records. MS Office, strong word processing and spreadsheet skills. Familiarity with the handling of biohazardous materials. Demonstrated ability to organize, motivate, empower, and build a cohesive team would be a distinct advantage. Physical Requirements (if applicable): Travel may be required.

NOTE:

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

LI-Hybrid Additional Information:

Compensation & Benefits:

For U.S.-based positions only, the annual base salary range for this role is $112,300.00 - $168,400.00 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. (Know Your Rights) Insulet Corporation is proud to be an equal opportunity employer. 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) Insulet employees are all focused on the same goal — to make a difference. Our relentless passion is to simplify life for people with diabetes. We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance. We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there. We foster and celebrate curiosity, innovation, and learning. Our teams work collaboratively and are empowered to drive the best actions for our customers. Our innovation spirit and customer-centric focus position us as global pioneers — leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.