Manufacturing Engineer (Onsite)

Company Overview

Insulet started in 2000 driven to achieve our mission of enabling 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 who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

We are looking for highly motivated, performance driven individuals who want to be part of building our Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview

We are seeking a skilled and motivated Manufacturing Engineer to join our dynamic team. The ideal candidate will have experience in a high-volume, highly automated manufacturing environment and will be responsible for ensuring the efficient production of our electro-mechanical medical devices. This role requires a strong background in problem-solving techniques, root cause analysis, lean methodologies, statistical process control, design of experiments (DOE), and validation techniques.

Responsibilities

• Continuous Improvement: Develop and drive continuous improvement efforts for manufacturing processes and equipment.

• Manufacturing Expansion: Support project deliverables for installation of new manufacturing equipment, manufacturing equipment upgrades, and new component introductions across various Insulet manufacturing sites

• Process Improvement: Identify and implement process improvements to enhance manufacturing efficiency, quality, and cost-effectiveness.

• Key Performance Indicators: Monitor and report on critical performance and process metrics; own the required efforts to ensure these KPIs are at or above target.

• Root Cause Analysis: Conduct structured root cause investigations using standardized templates and problem-solving tools.

• Validation: Develop and execute validation (IQ, OQ, TMV, CSV, PQ) protocols for new and existing processes and equipment. Write validation/qualification reports.

• Cross-Functional Collaboration: Work closely with Maintenance, Equipment Design, Controls, Operations, and Quality teams to ensure seamless production and continuous improvement.

• Documentation: Maintain accurate and detailed documentation of processes, experiments, and validation activities per industry GDP practices. Manage all documentation within Insulet Digital Systems (QMS, PLM, PDM).

• Compliance: Maintain a cGMP compliant environment and operate within FDA and ISO guidelines for Class II Medical Device manufacturing.

Required Skills and Competencies

• Proficient in Microsoft Office tools: Word, Excel, PowerPoint

• Working knowledge of statistical analysis software; Minitab and/or JMP preferred

• Working Knowledge of CAD Design and print reading; SolidWorks preferred

• Familiar with root cause analysis techniques (DMAIC, DMADV, Fishbone, etc.) and statistical process control (SPC).

• Familiar with experiment design (DOE) and validation techniques (IQ, OQ, TMV, CSV, PQ).

• Comfortable troubleshooting mechanical equipment both Semi and fully automated

• Basic knowledge of common challenges of high-volume component manufacturing methods (i.e. injection molding, stamping, springs, CNC milling/turning, etc.)

Education and Experience

• High School diploma and 7+ years of practical experience in Engineering in a highly regulated manufacturing environment (e.g. Medical, Aerospace, Automotive) or

• Bachelor’s degree in manufacturing engineering, mechanical engineering, or a related field and 2+ years of experience or

• M.S. in Engineering or Engineering Management, with 0-2 years of experience.

• Experience in the medical device industry is preferred. High-Volume Manufacturing and/or Automation Experience is a plus.

Additional Information

• The primary location for this position is in-person at our Acton location.

• Travel is estimated at 30-40%, primarily international, but will flex based on business needs.

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

Additional Information: