Process Development Engineer - St Paul, United States - Medical Engineering Consultants

Description

Job Purpose:
Develops and executes plans for major process related segments of complex product development projects. Compiles and analyzes process performance data to establish process design and specifications for newly designed or modified products. Plans and validates equipment and processes of newly designed products to internal and external requirements. Executes process development related activities on project. Reviews progress of projects; recommends appropriate revisions. Takes a leadership role in application and advancement of technologies developed by our client.


Job Responsibilities:
Oversee process design, development, characterization, and validation for products in development.
Work closely with R&D team, customers, and leadership to define process specifications and performance requirements.

Perform engineering and technical work involved in planning, organizing, and coordinating detailed information required to develop new products from concept to final product realization.

Develop and manage strategy to bring processes from feasibility to launch.
Contribute to early development phases and be the voice of design for manufacturability.
Identify suitable processes and equipment early in development and ensure robust manufacturable product design.
Assume responsibility for overall manufacturing process of new and existing products.
Devise new approaches to complex problems through revisions of standard technical principles.
Help prepare project plans, specifications, resource plans, and schedules for new product development.

Work closely with other engineers, technicians, contract manufacturers, assemblers, or other support personnel to oversee manufacturing products for development prototypes, design verification, process development and validation activities.

Identify critical processes, and develop master process validation plans including IQ, PC, OQ, PQ and external service validations requirements for development projects.

Work closely with other engineers and assemblers to characterize and validate equipment and processes.
Identify process inputs and outputs and develop strategies for how to monitor and control.

Identify process performance requirements (yield, capacity, capability, efficiency) that should be met before transfer to production and may be used as KPI's.

Required Qualifications:
Bachelor's Degree in Engineering, or equivalent Engineering degree.
5+ years' experience in engineering. 2+ years of which are in process engineering.
Must have hands-on experience and knowledge of QSR CFR 820, ISO 13485, ISO 14971 and other relevant standards.

*Sponsorship/ Corp to Corp is not available for this position.
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