Senior SW Design Quality Assurance Engineer, Cloud SW (Hybrid)

Position Overview:
The Senior SW Design Quality Assurance Engineer is responsible for ensuring new products conform to the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971. This person is responsible for maintaining a strong collaborative partnership with cross-functional team members. The SW Design Quality Assurance Engineer will serve as a Quality representative on Cloud-based product development projects to review design history file documentation and cloud related requirements, designs, and test documentation as well as other continuous improvement initiatives to support departmental, functional and corporate quality goals and priorities. This person will effectively communicate with all levels of the organization. This role will interface with other Insulet departments (e.g., Research and Development, Product Security, DevOps, Engineering, IT, and Regulatory Affairs).

Responsibilities:

• Ensures new product introduction quality deliverables are created and properly executed (e.g. Project Quality Plan and Risk Management Plan).
• Works with teams to establish measurable, valid product requirements.
• Supports Risk Management activities from product Concept through Commercialization.
• Supports DHF content completion, integrity, and regulatory and standards compliance, including identifying gaps, collaboratively communicating and working with team to resolve gaps.
• Reviews and approves design control documentation (e.g. plans, protocols, reports) ensuring compliance with the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971.
• Supports the review of environment qualification activities and deliverables (Installation Qualification/Operational Qualification)
• Provides guidance as needed to assure country specific compliance to the laws and regulations of the targeted market for distribution.
• Supports deployment for cloud releases supporting  new products and product changes.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues.
• Performs other duties as required.

Education and Experience

Minimum Requirements:

• A minimum of 5 years work experience in Software Quality Engineering within an FDA regulated environment.
• Degree in engineering/scientific/computer systems or equivalent experience.
• Experience with medical device software development
• Experience with software development lifecycles.
• Experience in creation and/or maintenance of quality documentation (SOPs, Templates).
• Experience and knowledge of FDA Quality System Regulations 21 CFR 820, ISO 13485, ISO 14971, IEC 62304
• Experience utilizing QMS PLM tools.
• Experience with Non-Product Software Tool validation
• Familiarity with various software development tools (e.g., configuration management, issue/defect tracking, requirements analysis, etc.).
• Excellent verbal and written communication skills.
• Ability to collaborate with individuals at multiple levels across the 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.

Preferred Skills and Competencies:

• ASQ, CSQE or other software quality certificates is a plus.
• Masters degree preferred
• Experience supporting cloud-based system as part of a medical device
• Knowledge of AWS is a plus

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 3x/week; may work remotely other days). #LI-Hybrid 

Additional Information:

The US base salary range for this full-time position is $85,125.00 - $127,687.50. 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.