Sr. Staff DQA Engineer (HW & Embedded SW) (Hybrid)

Insulet Corporation; Massachusetts; Hybrid; USD 90,000 - 150,000; Full time

Job summary

An innovative medical device company is seeking a Senior Staff Design Quality Assurance Engineer to lead Design Assurance and Quality Engineering activities throughout the development lifecycle. This role involves ensuring compliance with medical device standards and collaborating with cross-functional teams to support product development and lifecycle engineering. The ideal candidate will have extensive experience in FDA and ISO regulated environments, strong analytical skills, and the ability to manage critical project timelines. Join a forward-thinking organization dedicated to simplifying life for individuals with diabetes through cutting-edge technology and make a significant impact in the field of medical devices.

Qualifications

• 8+ years of experience in Quality within FDA or ISO regulated environments.
• Expertise in Design Control and compliance with medical device standards.

Responsibilities

• Lead Design Assurance and Quality Engineering activities for new product development.
• Ensure compliance with IEC 62304, ISO 14971, and related standards.

Skills

Effective verbal and written communication skills

Analytical and problem-solving skills

Ability to prioritize and manage project timelines

Collaboration and communication skills

Ability to influence people and projects

Education

BS degree in Electrical or Mechanical Engineering

Master’s degree

ASQ, CSQE or other software quality certificates

Tools

PLM

Configuration management tools

Issue/defect tracking tools

Requirements analysis tools

Job description

Sr. Staff DQA Engineer (HW & Embedded SW)(Hybrid)

Sr. Staff DQA Engineer (HW & Embedded SW)(Hybrid)

Job Title: Senior Staff Design Quality Assurance Engineer

Department: Design Quality Assurance

FLSA Status: Exempt

Position Overview:

Technical Lead for Design Assurance and Quality Engineering activities throughout the Development Lifecycle for new product development and sustaining engineering involving Hardware and Embedded Software Systems for Insulet Corporation. This includes ensuring that the development process is compliant with applicable standards, regulations and guidance documents for medical devices containing Embedded Software. This role will interface with other Insulet departments (e.g. Research and Development, Lifecycle Engineering, Operations, Engineering, Human Factors, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, and services to support our medical devices, partner integrations, and data analytics.

Responsibilities:

• Key member of cross functional development teams supporting development efforts for Hardware and Embedded Software Systems.
• Subject Matter Expert in Design Control to support the development organization. Provide oversight and support for the generation and approval of all Design History File deliverables.
• Subject Matter Expert ensuring compliance to IEC 62304, ISO 14971, 21 CFR 820, and ISO 13485.
• Provide guidance to the development organization on the generation and review of requirements & specifications, design documents, design verification plans, protocols, and reports, traceability matrices and other documentation as required.
• Provide technical expertise to Design Quality Assurance Organization supporting new product development and lifecycle engineering initiatives.
• Support quality related process/product improvement initiatives throughout the Development Lifecycle and DQA activities within the organization to align with industry best practices.
• Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements.

Education and Experience:

• ASQ, CSQE or other software quality certificates are beneficial.
• BS degree in an electrical engineering, mechanical engineering, or other engineering or scientific discipline. Master’s degree preferred.
• A minimum of 8 years work experience in Quality within an FDA, ISO, or other regulated environment and/or equivalent combination of education and experience.
• Experience in the development and implementation of effective Design Control Systems for medical devices.
• Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.
• Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and related FDA guidance documents.
• Familiarity with various software development tools (e.g. PLM, configuration management, issue/defect tracking, requirements analysis, etc.).

Skills/Competencies:

• Effective verbal and written communication skills.
• Experience collaborating and communicating with individuals at multiple levels in an organization.
• Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
• Strong analytical and problem-solving skills.
• Able to work effectively in a high-stress, high-energy environment.
• Ability to influence people and projects in a fast-moving environment.

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days).

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.

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.