Sr. Manufacturing Engineer, GSE (Onsite)

Position Overview :

The candidate will support early-stage feasibility and prototyping activities, manage technical aspects of component vendors, and ensure the component supply piece of the product development process meets targets for timing and performance. The candidate will work both on the addition of new manufacturing lines and equipment, as well as continuous improvement efforts for existing manufacturing processes and equipment.

The candidate will build and apply knowledge of Omnipod product function and manufacturing assembly processes to coordinate with equipment suppliers, CM counterparts, and various teams within Insulet to ensure the successful validation and performance of new and existing manufacturing equipment and processes.

The candidate will be responsible for KPIs for project budget and timing, as well as component supply performance, process yield, and efficiency once equipment is in production.

As part of providing support to the Global Manufacturing Engineering Group, the candidate will also carry out root cause investigations using structured problem-solving tools and will author and review quality system documentation such as validations, work instructions, SOPs, non-conforming material investigations, and tool files.

Responsibilities :

Drive product and process improvements in support of Insulet's Operations (3) main objectives :

• Best Quality
• Highest Efficiency
• Lowest cost
• Manage project deliverables for installation of new manufacturing equipment and manufacturing equipment upgrades.
• Support equipment validation and continuous improvement activities at Insulet manufacturing facilities.
• Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support.
• Monitor and report on yield and equipment up-time information; own the required efforts to ensure these KPIs are at or above target.
• Develop and drive Continuous improvement efforts.
• Generate validation / qualification (IQ, OQ, TMV, CSV, PQ) protocols, coordinate the execution of the validation / qualification protocols and write validation / qualification final reports.
• Possesses strong mechanical analysis skills.
• Analyze a product using mechanical engineering methods such as FBD analysis and fundamental physics.
• Use standardized root cause investigation templates and problem-solving tools to carry out non-conforming material investigations.
• Implement corrective and preventive actions.
• Support new product introduction initiatives.
• Travel to key suppliers to help them carry out critical investigations or improvement projects.
• Carry out duties in a quality system environment.
• At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing.
• Author and implement Engineering Change Orders.
• Up to 5% travel required, ability to travel internationally.
• Performs other duties as required.

Skills / Competencies :

Behavioral Competencies :

Decision Making - has a systematic and methodical approach to making decisions, seeks out and explores relevant information, thinks creatively beyond the immediate problem, assimilates facts quickly, challenges assumptions, and considers business implications of potential solutions.

Communication Skills - Conveys information effectively, actively listens, resolves conflict constructively.

Work Organization - Takes a structured, economical approach to resources including time, people, money, and equipment.

Problem Solving - Uses a systematic, methodical approach to gather facts, define problems, generate and implement solutions.

Initiative - Makes decisions and takes actions appropriately. Willing to take risks as circumstances require.

Planning Skills - Sets goals and priorities, thinks ahead, identifies activities and resources needed to achieve goals.

Perseverance - Achieves objectives by overcoming difficulties through tenacity and resilience.

Physical Requirements :

Able to work in Class 8 Cleanroom Environment for extended time in a standing position.

Education and Experience :

High School diploma and 10+ years of practical experience in Engineering within a highly regulated manufacturing environment; preferably in the medical device industry.

OR

BS. in Mechanical / Industrial / Electrical Engineering and 6+ years of experience in a highly regulated manufacturing environment; preferably in the medical device industry.

OR

MS. in Mechanical / Industrial / Electrical or Engineering Management with 5+ years of experience in a highly regulated manufacturing environment; preferably in the medical device industry.

NOTE : This position requires on-site working (requires on-site office / plant / lab work). #LI-Onsite

Additional Information :

The US base salary range for this full-time position is $92,400.00 - $138,600.00. 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.

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