Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Position Overview:

Performs engineering work related to planning, devising, or adapting methods to improve process effectiveness at captive and third party manufacturing sites. Examines components, equipment, processes, operations, and finished device design to identify improvement opportunities.

Responsibilities:
• At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing.
• Drive product and process improvements in support of Insulet’s CAPA system.
• Generate validation/qualification protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports.
• Author and implement Engineering Change Orders.
• Design and coordinate the construction manufacturing fixtures.
• Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support.
• Perform other duties as assigned.

Education and Experience:
• Bachelors of Science in Engineering discipline and/or equivalent combination of education and experience.
Minimum Requirements:
• 3-5 years’ work experience in a manufacturing environment is required.
• Experience in the medical device industry is preferred.

Preferred Skills and Competencies:
• Effective verbal and written communication skills.
• Ability to organize and judge priorities.
• Ability to generate and maintain accurate records.
• Ability to work well in a team environment with the ability to take personal ownership of projects as needed.
• Manufacturing process knowledge (Injection Molding, Metal Stamping/forming, PCB manufacture, Manual and automated assembly, decorating, extrusion and ultrasonic welding) a plus.
• Strong computer skills; MS Office / MS Project / Statgraphics.
• CAD (ProEngineer / Solidworks) experience desirable.

Physical Requirements:
• Potential overnight travel of approximately 33% of the work week.

Additional Information:

The US base salary range for this full-time position is $68,100.00 - $102,300.00. 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.