Insulet Corporation · 6 days ago
Senior Manufacturing Engineer, Test & Controls
Massachusetts, United States
Full-time
Hybrid
Mid, Senior Level
$95K/yr - $142K/yr
5+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The Sr. Manufacturing Engineer, Test & Controls is a hands-on technical contributor responsible for developing and optimizing manufacturing test systems for medical devices, ensuring compliance with product requirements and manufacturing capabilities.
Health CareMedicalMedical Device
Responsibilities
Develop and implement manufacturing test strategies for pilot and production lines, focusing on low-power embedded systems and analog/digital circuits
Design, source, and validate custom test fixtures and automated test systems
Collaborate with Electrical Engineering to define test requirements and ensure design for testability (DFT)
Author and execute test protocols and validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), in compliance with FDA regulations and ISO 13485 standards
Troubleshoot and resolve test-related issues on the manufacturing floor, including product hardware, software, and test system performance
Support process verification, validation, and documentation for new and existing products
Apply principles of electrical and system design to analyze failures and drive improvements in test and manufacturing processes
Support risk management, usability studies, and design validation processes
Interface with internal and external resources to source and qualify test equipment and components
Leverage data to drive problem resolution and continuous improvement
Support integration of data collection systems for quality, productivity, and traceability
Qualification
Required
BS in Electrical, Software, or Manufacturing Engineering with 7+ years of experience in medical device or other highly regulated manufacturing environment, or MS with 5+ years of experience
Proficiency in analog and digital circuit design, low-power embedded systems, and PCB layout principles
Strong experience with LabVIEW or similar test automation platforms
Familiarity with electrical engineering tools and instruments (oscilloscopes, multimeters, power analyzers, etc.)
Experience developing and validating electrical test systems and fixtures
Working knowledge of FDA design control guidelines and medical device regulatory requirements
Experience with design verification, risk management, and usability testing
Understanding of electrical safety and EMC standards for medical devices
Able to work in a Class 8 Cleanroom Environment
Strong communicator with the ability to collaborate effectively across engineering and manufacturing teams
Demonstrated ability to make sound, data-driven decisions in fast-paced environments
Proactive in identifying and implementing process and test improvements
Skilled at balancing multiple priorities and managing cross-functional projects
Maintains focus, adaptability, and resilience in hands-on technical settings
Preferred
Familiarity with servo drives, motion control, and industrial automation is a plus
Experience in testing wireless communication technologies (e.g. RF, BLE) and signal processing is a plus
Experience with SQL Server, Visual Basic, and networked data collection systems is a plus
Experience with Class II medical devices and cleanroom manufacturing environments is highly desirable
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
Company
Insulet Corporation
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.
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase