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). #LI-Hybrid 

Additional Information:

The US base salary range for this full-time position is $104,325.00 - $156,487.50. 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.