Process Development Engineer

Company Name:
Labrador LifeScience
Position Title: Biomedical Process Development Engineer I
Contract to Hire
Pay: $25/hr. to $30/hr. + OT

Position Summary:
Performs analyses to develop build processes that consistently produce products meeting the performance requirements. Provides technical information concerning manufacturing or processing techniques, materials, properties and process (advantages/limitations)
engineering
planning. Selects techniques to solve problems and make sound design/process recommendations.

Essential Functions:
Develop protocols, execute, and create reports for the following: installation qualifications (IQ's), test method validations (TMV's), operational qualification (OQ's), and process qualifications (PQ's).
ISO 13485
Manage program compliance with Quality Control requirements (i.e. Design Control, Process validation etc.).
Evaluate process and design alternatives based on Design for Manufacturability principles.
Understand principles of Cost of Goods Sold.
Understand IP issues relative to processes being developed.
Establish processes based on product specifications.
Maintain knowledge of new developments in manufacturing and design technologies.
Understand work environment issues (i.e. OSHA regulations, etc.).

Other Duties:
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Qualifications:
BS degree in Engineering or Technical Field required or equivalent experience; advanced degree preferred
0-2 years engineering experience required
Experience designing and testing medical devices preferred
Experience developing manufacturing processes and technologies and designing for manufacturability preferred.

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