Senior Design Assurance Engineer

BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience.
Minimum 5 years experience in the FDA regulated environment.

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. Identifies gaps, collaboratively communicates and works with team to resolve gaps.
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.
Performs other duties as required.

Master’s degree in engineering or technical or scientific discipline preferred.
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).
Experience with word processing, spreadsheet, database programs.