Team Lead, Post Market Engineering (Hybrid - Acton, MA)

Insulet Corporation•Acton, MA

3d•Hybrid

About The Position

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.

Requirements

BS/BA degree in business, engineering, or scientific discipline.
Proven leadership skills to engage, coach, mentor, and develop the team, inspire high quality and timely work.
6 years of combined education and experience as a lead in engineering, technical or scientific discipline.
Effective verbal communication and excellent technical writing skills.
Proven experience to organize, prioritize and follow through on multiple tasks with minimal supervision.

Nice To Haves

Preferred 2 years in a Quality related function working with QSR and/or ISO 13485.
General knowledge of performance metrics
Electrical and mechanical background strongly preferred.
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.)

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.