Position Overview: 

The Staff Manufacturing Engineer – New Product Introduction (NPI) is a senior-level individual contributor focused on the hands-on development, troubleshooting, and optimization of manual and semi-automated assembly processes for next-generation products. Working directly on the manufacturing floor, this role is responsible for ensuring that pilot production lines are capable, efficient, and ready to support early builds and design validation. The Staff Engineer will lead efforts to resolve real-time process issues, validate new equipment, and implement improvements that enhance product quality and manufacturability. This role will also interface with equipment vendors and internal design teams to source, fabricate, and set up custom assembly fixtures and equipment. A key responsibility is to gather and transfer process knowledge and lessons learned from the pilot line to support the design and development of fully automated production systems. This role is critical to ensuring Insulet’s future products are launched with robust, scalable, and high-quality manufacturing processes. 

Responsibilities: 

Serve as the technical lead for pilot manufacturing line setup, validation, and readiness for new product introductions 

Lead the installation, configuration, and optimization of manual and semi-automated assembly equipment to support early-stage builds 

Interface with equipment vendors and internal design resources to source, fabricate, and implement custom assembly fixtures and tooling 

Execute and document equipment and process validations (IQ, OQ, PQ, TMV, CSV) in compliance with regulatory and quality standards 

Troubleshoot and resolve real-time issues on the manufacturing floor related to equipment, tooling, and process performance 

Drive continuous improvement of pilot line processes to enhance yield, cycle time, quality, and efficiency 

Monitor and report on key performance indicators (KPIs) such as process yield, equipment uptime, and line efficiency 

Collaborate with cross-functional teams to ensure smooth knowledge transfer from pilot line to automation development teams 

Support DFM/DFA activities by providing feedback to R&D based on pilot line performance and manufacturability observations 

Lead structured root cause investigations and implement corrective and preventive actions (CAPAs) for process deviations and non-conformances 

Author and maintain quality system documentation including work instructions, SOPs, non-conforming material reports, and Engineering Change Orders (ECOs) 

Ensure all work complies with FDA regulations, ISO 13485, GMP, and internal quality standards 

 

Key Decision Rights: 

Technical lead for NPI manufacturing process design, setup, validation strategy, and equipment selection. 

Influence manufacturing process evolution and capacity expansion planning. 

 

Required Leadership/Interpersonal Skills & Behaviors: 

Skilled at anticipating technical challenges and aligning work with manufacturing needs 

Strong communicator with the ability to collaborate effectively across teams 

Demonstrated ability to make sound, data-driven decisions 

Experience mentoring peers and promoting a culture of continuous improvement 

Takes initiative to identify and implement process improvements 

Maintains focus, adaptability, and resilience in fast-paced, hands-on environments 

 

Required Skills and Competencies: 

Proficiency in manufacturing process development, automation, and validation. 

Strong command of statistical tools (Minitab, JMP) and data analysis techniques. 

Advanced proficiency in SolidWorks and engineering drawing interpretation. 

Deep understanding of Six Sigma, Lean Manufacturing, and structured problem-solving methodologies. 

Demonstrated success in leading complex NPI projects in a regulated environment. 

Strong project management and cross-functional leadership skills. 

Familiarity with challenges in assembly of molded components, stamped metals, springs, and micro-mechanisms. 

 

Education and Experience: 

BS in Mechanical, Industrial, or Electrical Engineering with 7+ years of experience in medical device manufacturing engineering. 

MS in Engineering or Engineering Management with 5+ years of relevant experience preferred. 

 

Additional Information: 

Able to work in a Class 8 Cleanroom Environment. 

Experience with Class II medical devices and cleanroom manufacturing environments is highly desirable. 

Role is based in Acton and the ideal candidate will be in office a minimum of 4 days a week 

Travel up to 10%, including international travel to suppliers and manufacturing sites. 

Additional Information:

The US base salary range for this full-time position is $113,550.00 - $170,325.00. 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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