Vernon Hills, IL

Engr 2, Mechanical

Job Description

Responsibilities :

Lead/co-lead Manufacturing/Design Transfer activities for NPD Projects
Manages cross-functional teams for Product Development/Sustaining projects
Develops, Maintains and Reports Project Timeline / Plan
Develops, Coordinates and Supports Manufacturing processes (product/equipment) at External Suppliers
Develops and Executes Test Method Validations / Gage R&R
Develops and Executes Component Qualifications
Develops and Executes Process Characterizations / Design of Experiments (DOE)
Develops and Executes Process Validation: IQ/OQ/PQ
Designs / Coordinates Facilities Modifications and MFG Line Layout
Develops Manufacturing Capacity Analysis
Designs, Selects and Evaluates Equipment and Tooling
Develops and submits for approval documentation/justification for assigned capital projects
Develops SOPs and Manufacturing Procedures.
Initiate/Implement applicable documentation changes
Complies with cGMP's, Quality Standards , and established policies and procedures
Executes other duties assigned by Supervisor

Requirements:

BS/MS Degree in Engineering (Industrial, Mechanical, Biomedical)
5+ years of experience with BS; 3+ years with MS in the following areas of the Medical device or pharmaceutical industries:
Manufacturing
New Product Transfers
R&D
Product / Process Development
Project Management / Design Control
Equipment / Process Qualification / Validation (IQ/OQ/PQ)
Test Method Validation / Gage R&R
Manufacturing Processes such as Machining, Molding, Forging, Assembly, Packaging
Materials and Process Characterization
Design of Experiments (DOE)
Manufacturing Line Design / Capacity Analysis
Equipment / Tooling Design, Selection and Evaluation
Packaging Validation
Root Cause Analysis / Investigation
SOP / Manufacturing Procedures Generation & Document Change Control
Product Financials & Supply Chain Structure Design

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