Job Description

Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Manufacturing Engineer (Medical Devices) and this a long term contract position.

This highly skilled manufacturing engineer will support manufacturing lines for both mature and new products. Responsibilities include providing daily support for existing manufacturing lines, continuous improvement efforts, as well as developing manufacturing equipment and assembly processes for new and existing products.

Essential Job Duties Provide daily engineering support for existing in-house manufacturing lines for NPI product line and mature manufacturing lines Lead root cause investigations and drive dispositions and corrective actions for assembly-related defects using Product and Process FMEAs as guidance for various non-conformances.

Support quality system compliance including ECO review and implementation, discrepant material dispositions, nonconformance evaluations, and quality notifications.

Troubleshoot, resolve, and document equipment and process malfunctions in compliance with GXP and Quality System requirements.

Assist in line transfer and line duplication activities. Support equipment and process qualification efforts (IQOQPQ and PPQs) Contribute to continuous improvement of product quality, throughput, and cost.

Utilize objective data and statistical analysis to inform and drive decisions. Projects included Manufacturing Process Instruction updates, Test Method Validations, equipment and aid design, line balancing efforts, capacity improvement projects, etc; and the documentation required Develop, document, and qualify (IQ/OQ/PQ/PPQ) new manufacturing and test processes using statistical tools such as Design of Experiments (DOE), Process Capability (Cpk), and Gage R&R. Specify and refine BOMs, workflows, and manufacturing travelers.

Revise manufacturing related risk documents including Process FMEAs, Manufacturing Line Specifications, and Equipment Specifications Support implementation of design improvements to existing products, including: Provide feedback to Design Engineering on Design for Manufacturability/Assembly (DFM/DFA) Assist in Design Verification and Validation (V&V) builds Coordinate cut-in/implementation in production. Provide manufacturing feedback for supplier change requests (SCRs). Support the task/responsibilities above related to new product introductions.

Required Skills and Experience

Strong 3D modeling/CAD experience (SolidWorks preferred) Foundation in design, fabrication, and assembly process development for complex mechanical assemblies.

Demonstrated understanding of component manufacturing processes such as injection molding, transfer molding, thermoforming, machining, stamping, and MIM.

Technical problem-solving skills with ability to identify root cause and drive corrective action (Fishbone, 8D Analysis) Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments,) in data analysis for process development and problem-solving.

Effective communication skills (verbal, written, and presentation) and comfortable interacting with production technicians, product design engineers, planners, buyers, clinical engineers, supplier engineers, and upper management.

Minimum B.S. Mechanical Engineering or related technical discipline.

5+ years with a B.S, or 3+ years, with an M.S of experience as a process or manufacturing engineer supporting products with significant mechanical content.

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