Senior Quality Engineer, NPI Programs

Diabetes Youth Families

Senior Design Assurance Engineer at Insulet ensuring quality and compliance in medical device development. Collaborating with teams to manage risk and mentor engineering personnel in FDA-regulated environment.

Posted 7/25/2026full-timeActon • Massachusetts • 🇺🇸 United StatesSenior💰 $87,300 - $130,950 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance within FDA regulated environments, focusing on compliance with QSR Part 820, ISO 13485, and ISO 14971. Proficient in risk management, project direction, and systematic problem-solving methodologies for medical device product development.

Highest-signal resume keywords

Quality AssuranceFDA Regulated Environment ExperienceQSR Part 820 ComplianceISO 13485 KnowledgeStatistical Methods

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Project Quality PlanRisk Management PlanDesign Control DocumentationDHF Content CompletionStatistical Process ControlSampling PlansGauge R&RDesign of ExperimentsVerification and ValidationETO Sterilization Methods

Soft Skills

CoachingMentoringProblem SolvingCommunicationTeam Collaboration

Industry Keywords

Medical DeviceRegulatory ComplianceQuality System RegulationRisk ManagementManufacturing Process Development

About the role

Key responsibilities & impact

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.
Review and approve design control documentation (e.g. plans, protocols, reports) ensuring compliance with the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971.
Provide guidance as needed to assure country specific compliance to the laws and regulations of the targeted market for distribution.
Supports manufacturing process development & qualification for new product commercialization 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.

Requirements

What you’ll need

BS degree in engineering, a technical or scientific discipline and 5+ years' experience; or equivalent combination of education and experience.
5-7 years’ experience in the FDA regulated environment.
Experience in Quality in an FDA regulated industry.
Experience with QSR Part 820, ISO 13485 and ISO 14971.
Experience with ETO sterilization methods preferred.
Experience with methods and standards for the design, verification, and validation of medical device products.
Experience with statistical methods (e.g. statistical process control, sampling plans, gauge R&R, and design of experiments).

Benefits

Comp & perks

Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs