Position Overview:
The Post Market Engineering Team Lead plays an integral part of Insulet’s Quality Department as a hands-on technical leader conducting post market investigations of FDA approved medical devices. The role requires strong organization skills, attention to detail while working in cross functional teams to accomplish of departmental and company goals.
Responsibilities:
Provide work leadership/mentorship to team members, including but not limited to, training support on processes and procedures.
Performs complex tasks to ensure compliance with quality standards.
Track daily team metrics to ensure performance targets are achieved
Works with failure analysis engineers and other Post Market team members to ensure effective inspection, protocols, and procedures are implemented and maintained.
Assists in the development of protocols and standards to meet quality specifications and recommends procedural changes.
Perform product evaluation including root cause/troubleshooting and failure analysis.
Review applicable DHR’s, NCMR’s, CAPA’s, and deviations associated with individual complaints.
Summarize investigations with Root Cause Analysis and drive further action when appropriate.
Manages, facilitates, and participates in Continuous Improvement projects.
Approve / Sign-off work of failure analysis engineers and associates.
Gather, evaluate, and trend product reliability data.
Assist in cross-functional special projects.
Performs other duties as assigned.
Education and Experience:
Minimum Requirements:
BS/BA degree in business, engineering, or scientific discipline pr equivalent.
Preferred Skills and Competencies:
Proven leadership skills to engage, coach, mentor, and develop the team, inspire high quality and timely work.
Strong experience in combined education and experience as a lead in engineering, technical or scientific discipline.
Preferred work experience in a Quality related function working with QSR and/or ISO 13485.
General knowledge of performance metrics
Electrical and mechanical background strongly preferred.
Effective verbal communication and excellent technical writing skills.
Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision.
Prior experience working in a regulated industry (medical device) and/or experience working in a bio-hazard/lab environment preferred.
Experience creating and analyzing charts and Pareto charts in MS Excel a plus.
Experience or certification in Lean Six Sigma, SPC, ASQ, and/or ISO process controls a plus.
Excels at generating and maintaining organized and accurate records.
Complaint management software skills a plus. (i.e. Salesforce, Trackwise, PLM, etc.)
Physical Requirements (if applicable):
Sitting 70%, Standing 30%
Frequent lifting <5lbs
Occasional (<5% of time) handling (push/pull) up to 50lbs
Ability to operate basic hand tools
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!
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