Associate Manufacturing Engineer

Associate Manufacturing Engineer

• Translates requirements into new solutions - Develops requirements and specifications for new and existing engineering designs.

• Design - Proposes designs, implements or assesses designs and verifies parts or components for low complexity solutions.

• Develops Simulations & Prototypes - Develops simulations or prototypes for new / modified designs and performs engineering analysis and testing.

• Implements the design of new products and/or product improvements - Implements the design for parts or components and ensures designs meet established requirements.

• Responsible for updating / creating detailed design specifications.

• Verifies Solution -Responsible for integration, protocol development and verification of designs.

• Documenting and Managing Change - Justifies changes, quality and regulatory information, and manufacturing readiness information.

• Completes change documentation to include technical rationale and formal verification test results.

• Advances Engineering Expertise - Maintains current technical skills and functional area expertise.

• Anticipates and/or Develops/Applies Risk Mitigation - Reviews engineering technical risks and take appropriate action. Provides input into risk management documentation including FMEA and risk analyses.

• Collaborates across functional areas - Exchanges information with product team members, scientists, engineers, and other systems development personnel.

• Ensures quality through design Techniques and Design Alternatives - Participates in Engineering Design Reviews utilizing Engineering Procedures and Engineering Tools and incorporates recommendations.

• Performs Investigations - Participates in investigations to determine root cause for low complexity issues.

• Arrives at timely conclusions.

• Maintains adherence to the Quality System -Implements and maintains the effectiveness of the quality system. Follows functional area policies and procedures.

• Utilizes appropriate experimental, statistical and engineering tools.

• Obtains Customer Feedback for new and/or Improve Products - Gathers inputs from internal sources and from members of the project’s cross functional team to help meet product needs.

• Selects, builds and maintains Third Party Manufacturer (TPM) product and partner relationship - For Third Party Manufactured products, assesses the assigned part / component or subsystem ability to meet corresponding requirements.

• Strategic Orientation -Ensures activities are focused on team priorities.

• Works with cross functional team in collaborative environment.

• Bachelor’s Degree In an engineering or closely related discipline or an equivalent combination of education and work experience

• 0-2 years of related work experience

• Applies engineering technical knowledge for specified engineering discipline

• Knowledge of regulations and standards affecting IVDs and biologics is desired

• Bachelor’s Degree in Mechanical, Electrical or Biomedical Engineering, preferred

• Manufacturing engineering experience (e.g. developing instructions for building of product, etc.) -- from manufacturing company

• Experience with SolidWorks, DFA (Design for Assembly), or any other CAD system, CATIA, etc.

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