Engineer IV, Commercial Device Engineer, ASQ Senior

Katalyst Healthcares & Life Sciences - Lexington, MA

ContractEstimated: $80,000 - $110,000 a year
Job Description:
Candidate will support current Commercial Devices Engineering (CDE) projects for on-market support and market expansion.
Primary work will be for Administration System Qualification (ASQ) for drug delivery devices.
Secondary area of focus will be in supporting multiple medical device change control products for commercial vial reconstitution products.
Position will include global collaboration with technical staff, and direction and supervision of a technical report to meet established commitments.
Position will include writing protocols, conducting engineering laboratory testing under direction of supervisor, analysis of data and writing of reports, assuring technical analysis of data is appropriate.
Communication of status to senior management through regulatory scheduled project review meetings, and strong communication skills is required.

Experience and Experience:
BS or BS / MS Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Plastics/Polymer Engineering.
Strong interpersonal communication skills, ability to juggle multiple priorities, project management knowledge, device design control methodology, protocol / report writing.
Additional Skills MS Word, Project, PowerPoint, Excel and Statistical Analysis.