Design Assurance Engineer

 

Position overview:

This position provides expertise and guidance to product development projects in the area of design controls and compliance.  It requires experience in the medical device industry with a working knowledge of FDA's Quality System requirements (QSR), and ISO 13485 as it relates to Design Control. Candidates considered appropriate will be those who have strong communication skills, strong engineering background, and a basic understanding of quality principles.

 

JOB / DUTIES / RESPONSIBILITIES

• Serve as the quality team member on new product development teams, providing guidance in the area of design control and compliance.
• Quality Planning including Insulet and Supplier Inspection method development and validation.
• Provide support to product development teams in the areas test protocol & report development for verifications and validations.
• Knowledge of basic statistical and engineering principals is essential.
• Document review and approval of documents related to new product development activities (ie: Drawing releases, ECO’s, Protocols).
• Support Risk management activities (FMECA’s).
• All other duties as assigned.

JOB QUALIFICATIONS

Knowledge / Education

• Bachelors of Science or Technology in Engineering.
• Demonstrated working knowledge of engineering.

Job Experience

• Minimum of 2 years in the Medical Device Industry or other trelevant experience.

Skills / Competencies

• Effective verbal and written communication skills.
• Ability to communicate at multiple levels of an organization.
• PC skill, word processing, spreadsheet, database.
• Ability to organize and judge priorities.
• Ability to generate and maintain accurate records.

Qualified applicants please submit resumes to: careers@insulet.com