Senior Director, Design Quality Assurance (Hybrid - Acton, MA.) at Insulet in Acton, Massachusetts

Job Description:

We are seeking a highly experienced and motivated Senior Director of Design Quality Assurance to lead our Design Quality Assurance team. This strategic role is critical in ensuring that our medical devices (single use as well as durable equipment) meet our design requirements and are designed and developed in compliance with regulatory requirements and industry standards. Scope includes standalone software, applications, embedded software, cloud-based solutions, as well as hardware and electronics (PCBAs, electronic devices, etc). This includes electrical and safety testing, shelf life, and durability considerations.

The ideal candidate will have a strong background in design controls, risk management, and general quality within the medical device industry, with a particular focus on software and digital health technologies. This role partners closely with the technical and operations teams as well as our partners.

Responsibilities:

• Lead and manage the Design Quality Assurance team, providing strategic direction and oversight. Select, develop, and lead managers and Design Assurance Engineers on design control compliance requirements, ensuring product inputs are clearly defined and design verification and validation activities are appropriate and compliant.


• Drive risk management activities throughout the development process and through the product life cycle.


• Lead and support design related (process and product) CAPAs and continuous improvement activities.


• Ensure a well-functioning feedback loop between issue identification (post market signals, defect review board, etc) and product design improvements.


• Lead Design Quality Assurance resources as they relate to product launches, appropriately matching skill set of individual direct reports to demands of projects, prioritizing efforts, anticipating technical issues and assuring successful project outcomes.


• Provide leadership, mentorship, and accountability to Design Quality Assurance staff, fostering a culture of continuous improvement and excellence.


• Own and lead regular and robust design reviews that provide assessment of issues, risks, and resource requirements for all phases of NPI projects. Key member of Technical Review Board for design changes.


• Develop and implement Design Quality Assurance policies and procedures to ensure compliance with FDA, ISO 13485, and other relevant regulations.


• Participate in oversight of the design control process for software, applications, and cloud-based solutions, including risk management, design verification and validation, and design transfer, collaborating with other quality functions on the latter.


• Collaborate with cross-functional teams, including R&D, Regulatory Affairs, IT, Commercial, and Strategy, to ensure quality is integrated into all phases of product development. This includes coordination serving as primary point of contact with external partners in Quality and Design considerations.


• Partner with engineering teams (New Product Introduction, Life Cycle / Sustaining, Manufacturing, Supplier, Ops Quality Engineering) to drive design related process and product improvements.


• Partner with commercial and franchise teams to align quality assurance initiatives with business objectives and market needs. Demonstrate a strong "business partner" approach and attitude providing creative and innovative solutions that meet quality standards


• Support (and conduct where appropriate) internal audits. Support external audits by regulatory bodies by serving as Subject Matter Expert for Design Controls.


• Deploy and own Design Controls related metrics to ensure compliance, process efficiency, and continuous improvement. Use data-based decision making to ensure process is meeting the needs of the business.


• Promote awareness of design controls, user requirements, risk management, change control, and verification and validation processes across R&D and new development teams.


• Stay current with industry trends and regulatory changes, particularly in the areas of software and digital health, to ensure the company remains compliant and competitive.


• Supports the Partner Management Process, ensuring strategic and tactical alignment between Insulet and our key technology partners from a Quality perspective.


• Performs other duties as required.

Minimum Requirements:

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field


• Minimum of 15 years of experience in design quality assurance within the medical device industry, with at least 10 years in a leadership role.


• In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards, along with associated audits and inspections.


• Demonstrated experience managing and supervising diverse and remote teams.

Preferred Skills and Competencies:

• Advanced degree preferred


• Proven experience with design control processes, risk management, and product lifecycle management for software and digital health technologies.


• Strong analytical and problem-solving skills.


• Excellent communication and interpersonal skills.


• Ability to work effectively in a fast-paced, dynamic environment.


• Able to make decisions quickly based on vague or imperfect information.


• Up to 20% travel (some international travel required)

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 $204,900.00 - $307,350.00. 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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