SENIOR SUSTAINING ENGINEER

SUMMARY:

Senior engineer needed to evaluate and support design change and control responsibilities for a medical device production operation.

DUTIES & RESPONSIBILITIES:

* Design change evaluation, cost assessment, and related qualification, validation and project management

* Produce relevant, QMS-compliant documentation

* Collaboration with related departments and functions through team meetings and other communications

* Other duties, as required

QUALIFICATIONS & REQUIREMENTS:

* 7 years of relevant production experience including substantial experience in medical device manufacturing and quality, with an emphasis on design change management and design control

* Proven experience with statistical analysis and process & equipment validation, (including development of validation protocols) as well as expertise in test methodology and execution for products and materials

* Experience with prototyping and/or manufacturing catheters

* Relevant BS degree, mechanical engineering preferred

LOCATION:

Work will be performed onsite in the greater Philadelphia area.