Insulet Corporation
Sr NPI and Validation Engineer (Onsite - Acton, MA)
Acton, Massachusetts, USA · Senior
Sponsorship not specified$95k-$142kDetected 7 hours ago
RESTData AnalysisSupply ChainProcess ImprovementRoboticsCAMGMPFDA RegulatoryMedical DevicesResearchLeadershipCommunicationCollaborationProblem SolvingOrganizational SkillsActuatorsGxPRegulatory Affairs
About the role
- This role will interface with other Insulet departments (e.g.IT, Manufacturing, Management, Operations, Research and Development, and Regulatory Affairs).
- The Senior NPI and Validation Engineer is a critical member of the Global NPI and Validation Engineering team.
Responsibilities
- Quality Lead for Design Assurance of IT GxP and non-GxP systems ensuring compliance to applicable regulations including ISO 13485, FDA Quality System Regulation 21 CFR Part 820 and General Principles of Software Validation.
- Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation
- Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements.
- Support development teams on the validation of software tools.
- 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.
Requirements
- Must be able to handle multiple responsibilities concurrently.
Nice to have
- BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience.
- Master's degree preferred.
- Familiarity with GAMP 5 guidance.
- Experience with a risk-based approach to validate computerized systems, Commercial off the Shelf (COTS) software and SW Tools.
- A minimum of 5 years of experience in Software Quality Engineering within an FDA, ISO or other regulated environment.
- Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.
- ASQ, CSQE or other software quality certificates are beneficial.
- Expertise in data analysis tools such as DOE and process development
Skills
- Effective verbal and written communication skills.
- Experience collaborating and communicating with individuals at multiple levels in an organization.
- Strong analytical and problem-solving skills.
- Able to work effectively in a high-stress, high-energy environment.
- Mechanical aptitude, technical ability, ability to read and understand technical drawings and manuals.
- Technical knowledge of cam driven linkages, discrete component assembly, and automation
- Familiarity with machine user interfaces (HMIs / GUIs)
- Have strong interpersonal and communication skills
- Excellent attention to detail, organizational skills, and rigorous process discipline
- Thirst for knowledge and intense curiosity
Compensation
- Compensation & Benefits:For U.S.-based positions only, the annual base salary range for this role is $94,600.00 - $141,850.00This position may also be eligible for incentive compensation.We offer a comprehensive benefits package, including:
Company info
- We are looking for highly motivated, performance-driven individuals to be a part of our expanding team.
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