Senior Staff Engineer, Design QA, Hardware and Embedded SW
4 weeks ago
At Insulet Corporation, we're committed to empowering our customers to live healthier lives through innovative technology. As a Senior Staff Engineer, Design QA, Hardware and Embedded SW, you'll play a critical role in ensuring the development process for our medical devices is compliant with applicable standards, regulations, and guidance documents.
This includes overseeing Design Assurance and Quality Engineering activities throughout the Development Lifecycle for new product development initiatives involving Hardware and Embedded Software Systems. You'll interface with various Insulet departments, including Research and Development, Lifecycle Engineering, Operations, Engineering, Human Factors, and Regulatory Affairs, as well as external parties on issues related to product development, launched product support, and services.
Key Responsibilities:
- Lead cross-functional development teams supporting development efforts for Hardware and Embedded Software Systems.
- Provide oversight and support for the generation and approval of all Design History File deliverables.
- Ensure compliance to the Software Development Life Cycle (IEC and FDA Guidance on Software Contained in a 510(k) Submission).
- Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements.
- Provide technical expertise to Design Quality Assurance Organization supporting new product development and lifecycle engineering initiatives.
Requirements:
- BS degree in Electrical Engineering, Mechanical Engineering, Systems Engineering, Physics, or Science degree.
- A minimum of 8 years work experience in Design Assurance/Quality/Product Design and Development within an FDA, ISO, or other regulated environment.
- Proven experience delivering successful products to market.
- Subject Matter Expert for Design Controls (FDA 21 CFR Part 820), and Design and Development /Product Realization (ISO)
Preferred Skills and Competencies:
- Master's degree preferred.
- ASQ, CQE or other quality certificates are preferred.
- Demonstrated ability to collaborate with individuals at multiple levels across the organization.
-
Senior Staff Embedded Software Architect
4 weeks ago
Acton, Massachusetts, United States Insulet Corporation Full timeAt Insulet Corporation, we're on a mission to enable our customers to enjoy simplicity, freedom, and healthier lives through our innovative Omnipod product platform.We're seeking a highly motivated and performance-driven Staff Embedded Software Architect to join our expanding Research & Development Architecture team.This individual will be responsible for...
-
Senior Software Engineer
1 month ago
Acton, Massachusetts, United States Insulet Corporation Full timeJob DescriptionInsulet Corporation is seeking a highly skilled Senior Software Engineer to join our Research and Development team. As a key member of our team, you will be responsible for designing, developing, and testing embedded system software for new and existing Insulet products.The ideal candidate will have a strong background in software engineering,...
-
Senior Embedded Software Architect
4 weeks ago
Acton, Massachusetts, United States Insulet Corporation Full timeAt Insulet Corporation, we are seeking a highly skilled Senior Staff Embedded Software Architect to join our Research & Development Architecture team. This individual will be responsible for making significant contributions to software project initiatives associated with product development and improvements.This person will have a wide range of experience...
-
Embedded Software Development Specialist
4 weeks ago
Acton, Massachusetts, United States Oxford Global Resources Full timeJob Summary:We are seeking a highly skilled Firmware Systems Engineer to join our team at Oxford Global Resources. As a key member of our team, you will be responsible for executing a complete embedded software development lifecycle, creating scalable and optimized Firmware software systems.Key Responsibilities:Design and implement software of embedded...
-
Senior Mechanical Engineer
4 weeks ago
Acton, Massachusetts, United States Phantom Staffing Full timeJob Overview:We are seeking a talented Senior Mechanical Engineer to lead the design and development of advanced electro-mechanical laboratory soil testing equipment. This role involves spearheading the creation and integration of electro-mechanical systems, ensuring seamless operation of mechanical and electrical components.Key Responsibilities:Develop...
-
Senior Mechanical Engineer Position
4 weeks ago
Acton, Massachusetts, United States Phantom Staffing Full timeSenior Mechanical Engineer Job Overview:We are seeking a talented Senior Mechanical Engineer to lead the design and development of advanced electro-mechanical laboratory soil testing equipment. This role involves spearheading the creation and integration of electro-mechanical systems, ensuring seamless operation of mechanical and electrical components.Key...
-
Senior Software DQA Engineer
1 month ago
Acton, Massachusetts, United States Insulet Corporation Full timeJob DescriptionInsulet Corporation is seeking a highly motivated and experienced Senior Software DQA Engineer to join our team. As a key member of our software development team, you will be responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and for...
-
Staff Software Engineer
4 weeks ago
Acton, Massachusetts, United States Insulet Corporation Full timeJob DescriptionInsulet Corporation is seeking a highly motivated and experienced Software Engineer to join our Data Products Team. As a key member of our team, you will be responsible for designing, developing, and testing cloud software for new and existing Insulet products.Key Responsibilities:Design and develop cloud software for Insulet productsWork...
-
Electrical Engineer
4 weeks ago
Acton, Massachusetts, United States Insulet Corporation Full timeAt Insulet Corporation, we are seeking an experienced Electrical Engineer to join our team in the design and development of low power battery operated medical devices electronics.This is an exciting opportunity to work on innovative technology that enables our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product...
-
Senior Software Quality Assurance Engineer
4 weeks ago
Acton, Massachusetts, United States Insulet Corporation Full timeJob Title: Senior Software Quality Assurance EngineerJob Summary:Insulet Corporation is seeking a highly motivated and experienced Senior Software Quality Assurance Engineer to join our team. As a key member of our software development team, you will be responsible for ensuring the quality and reliability of our medical devices.Responsibilities:- Create and...
-
Senior Staff System Architect
4 weeks ago
Acton, Massachusetts, United States Insulet Corporation Full timeAt Insulet Corporation, we are dedicated to enabling our customers to enjoy simplicity, freedom, and healthier lives through the use of our Omnipod product platform. Our innovative technology is wearable, waterproof, and lifestyle accommodating, improving the lives of hundreds of thousands of patients over the last two decades.We are seeking a highly...
-
Senior Staff Engineer
4 weeks ago
Acton, Massachusetts, United States Geosyntec Consultants Full timeOverview:We are seeking a highly skilled Senior Staff Engineer to join our sediment and waterfront remediation practice. As a key member of our team, you will apply your engineering expertise to projects involving investigations, design, and construction support for the remediation of sediment sites throughout the United States.About Geosyntec...
-
Senior Staff Engineer
4 weeks ago
Acton, Massachusetts, United States Geosyntec Consultants Full timeJob Summary:We are seeking a highly skilled Senior Staff Engineer to join our sediment and waterfront remediation practice. The successful candidate will apply engineering skills to projects involving investigations, design, and construction support for the remediation of sediment sites throughout the United States.Key Responsibilities:Develop strategies to...
-
Principal Product Security Architect
4 weeks ago
Acton, Massachusetts, United States Insulet Corporation Full timeJob Title: Principal Product Security ArchitectCompany Overview: Insulet Corporation is a leading manufacturer of wearable medical devices. We are committed to delivering innovative products that improve the lives of our customers.Job Summary: We are seeking a highly skilled Principal Product Security Architect to join our team. As a key member of our...
-
Staff Mechanical Design Engineer
4 weeks ago
Acton, Massachusetts, United States Insulet Corporation Full timeJob SummaryInsulet Corporation is seeking a highly motivated and performance-driven Staff Mechanical Design Engineer to join our expanding team. As a key member of our design team, you will be responsible for designing and developing Insulet's next-generation wearables and platform extensions.Key ResponsibilitiesDesign and develop innovative medical devices,...
-
Senior Staff System Architect
4 weeks ago
Acton, Massachusetts, United States Insulet Corporation Full timeAt Insulet Corporation, we are seeking a highly skilled Senior Staff System Architect to join our team. This role will be integral in delivering new capabilities to class II/III medical devices from concept to commercialization.The ideal candidate will have a strong understanding of engineering and scientific fundamentals as well as end-to-end product...
-
Staff Mechanical Design Engineer, R&D Position
4 weeks ago
Acton, Massachusetts, United States Insulet Corporation Full timeCompany OverviewInsulet Corporation is a leading medical device company that has been improving the lives of hundreds of thousands of patients with insulin-requiring diabetes since 2000.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,...
-
Manufacturing Engineer
4 weeks ago
Acton, Massachusetts, United States General Atomics and Affiliated Companies Full timeJob SummaryWe are seeking a skilled Manufacturing Engineer to support the production process with a focus on designing, developing, and implementing new or revised production processes for the efficient and economical fabrication of parts, components, sub-assemblies, and final assemblies.Key Responsibilities* Develops, implements, and maintains methods,...
-
Acton, Massachusetts, United States General Atomics and Affiliated Companies Full timeGeneral Atomics and its affiliated companies are seeking a highly skilled Electrical Engineer to support the development of EO/IR space-based Payloads launched into various earth orbits.This is an exciting opportunity to work on the technical and performance execution of both conceptual and hardware design of Payload electrical subsystems.The engineer will...
-
Senior Water Resources Engineer or Scientist
1 month ago
Acton, Massachusetts, United States Geosyntec Consultants Full timeJob Overview:Geosyntec Consultants is seeking a highly skilled and experienced Senior Water Resources Engineer or Scientist to join our team in the Bedford, New Hampshire, Acton, Massachusetts, or Hamilton, Massachusetts office. The successful candidate will provide leadership and client development specifically in water resources engineering, watershed...