Senior Staff Engineer, Design QA, Hardware and Embedded SW (Hybrid)

$99,600 - $149,700/Yr

Insulet Corporation - Acton, MA

Full-time - Senior

Hybrid - Acton, MA

Miscellaneous Manufacturing

About the position

The Senior Staff Engineer, Design QA, Hardware & Embedded Software Systems at Insulet Corporation will serve as a Technical Lead for Design Assurance and Quality Engineering throughout the Development Lifecycle for new product initiatives. This role focuses on ensuring compliance with standards and regulations for medical devices, particularly those involving Embedded Software, while collaborating with various departments and external parties to support product development and lifecycle engineering.

Responsibilities

• Key member of 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.
• Subject Matter Expert for Risk Management Activities for complex systems in compliance with ISO14971.
• Ensure compliance to the Software Development Life Cycle (IEC 62304) 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 guidance on the generation and review of requirements & specifications, design documents, design verification plans, protocols, and reports.
• Support quality related process/product improvement initiatives throughout the Development Lifecycle and DQA activities.

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 13485).
• Proficient with Medical Device regulations (IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, and cybersecurity).
• Excellent project team skills; experience working collaboratively under a Quality Management System (QMS).

Nice-to-haves

• Master's degree preferred.
• ASQ, CQE or other quality certificates are preferred.
• Demonstrated ability to collaborate with individuals at multiple levels across the organization.
• Ability to prioritize and manage critical project timelines in a fast-paced environment.
• Strong analytical and problem-solving skills.

Benefits

• Hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days).