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 developmentExperience 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 62304Experience utilizing QMS PLM tools.Experience with Non-Product Software Tool validationFamiliarity 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 preferredExperience supporting cloud-based system as part of a medical deviceKnowledge 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.

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.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

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.

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