Manufacturing Engineer (Onsite - Acton, MA)

Insulet Corporation•Acton, MA

5d•$76,400 - $114,575•Onsite

About The Position

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. 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. This position requires on-site working (requires on-site office/plant/lab work).

Requirements

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.)
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.
3-5 years’ work experience in a manufacturing environment is required.
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.
Strong computer skills; MS Office / MS Project / Statgraphics.

Nice To Haves

Experience in the medical device industry is preferred.
High-Volume Manufacturing and/or Automation Experience is a plus.
Manufacturing process knowledge (Injection Molding, Metal Stamping/forming, PCB manufacture, Manual and automated assembly, decorating, extrusion and ultrasonic welding) a plus.
CAD (ProEngineer / Solidworks) experience desirable.

Responsibilities

Develop and drive continuous improvement efforts for manufacturing processes and equipment.
Support project deliverables for installation of new manufacturing equipment, manufacturing equipment upgrades, and new component introductions across various Insulet manufacturing sites.
Identify and implement process improvements to enhance manufacturing efficiency, quality, and cost-effectiveness.
Monitor and report on critical performance and process metrics; own the required efforts to ensure these KPIs are at or above target.
Conduct structured root cause investigations using standardized templates and problem-solving tools.
Develop and execute validation (IQ, OQ, TMV, CSV, PQ) protocols for new and existing processes and equipment. Write validation/qualification reports.
Work closely with Maintenance, Equipment Design, Controls, Operations, and Quality teams to ensure seamless production and continuous improvement.
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).
Maintain a cGMP compliant environment and operate within FDA and ISO guidelines for Class II Medical Device manufacturing.
Drive product and process improvements in support of Insulet’s CAPA system.
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.