Engr 2, Mechanical

Job Description Must Have Requirements Able to work On-site at Vernon Hills location Proficiency with SolidWorks Ability to identify the Critical to Quality (CTQ) requirements Essential Job Functions: 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 Education and/or Experience: 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 Experience in the following: 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

Created: 2025-10-04