Manufacturing Engineer

Insulet; Acton (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

Join a leading medical device manufacturer committed to innovation and quality. As a Manufacturing Engineer, you'll play a crucial role in ensuring efficient production of electro-mechanical devices. This dynamic position involves driving continuous improvement, supporting new product introductions, and collaborating with cross-functional teams. You'll utilize your expertise in problem-solving, statistical analysis, and validation techniques to enhance manufacturing processes. If you're passionate about making a difference in the medical field and thrive in a high-volume environment, this is the perfect opportunity for you.

Benefits

Career Growth Opportunities

Innovative Work Environment

Professional Development

Impactful Work on Life-saving Devices

Qualifications

• 7+ years of practical experience in a regulated manufacturing environment.
• Experience in the medical device industry is preferred.
• High-Volume Manufacturing and/or Automation Experience is a plus.

Responsibilities

• Develop and drive continuous improvement efforts for manufacturing processes.
• Conduct structured root cause investigations using standardized templates.
• Maintain accurate documentation of processes and validation activities.

Skills

Problem-solving techniques

Root cause analysis

Lean methodologies

Statistical process control

Design of experiments (DOE)

Validation techniques

Microsoft Office (Word, Excel, PowerPoint)

Statistical analysis software (Minitab, JMP)

CAD Design (SolidWorks)

Troubleshooting mechanical equipment

Education

High School diploma

Bachelor’s degree in manufacturing engineering

M.S. in Engineering or Engineering Management

Tools

Minitab

JMP

SolidWorks

Job description

Insulet, the makers of the OmniPod, is a leading medical device manufacturer. We are committed to innovation, quality, and excellence in our products and processes.

Job Description:

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.

Key Responsibilities:

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

New Product Introduction: Support project deliverables for installation of new manufacturing equipment, manufacturing equipment upgrades, and new component introductions.

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.

Travel: Up to 5% travel required; Ability to travel internationally (North America and APAC)

Qualifications:

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.

Skills:

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.)

Why Join Us:

Innovative Environment: Be part of a team that values creativity and innovation.

Career Growth: Opportunities for professional development and career advancement.

Impact: Contribute to the production of life-saving medical devices.

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

Additional Information:

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.

Automate injectable drug delivery with the customizable OmniPod by Insulet. See how it's improving lives with better adherence and seamless delivery.