We are searching for a Manufacturing Engineer who will be responsible for Quality improvements, Cost improvements and implementation of customer driven Design improvements.
[*] The successful candidate will be responsible for:
[*] Cost and Process Improvements:
Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, etc.
Quality Engineering Support for Design Control Process - Develop and implement project Quality Plan, review and approve to Design Specifications, Design verification and validation protocols, facilitate and participate in design reviews, develop quality-engineering deliverables and assure Design History File (DHF) is updated.
Lead continuous improvement projects.
Designs manufacturing equipment, processes and fixturing. Supplies layouts, BOM’s machine programming, user manuals, labels, regulatory information, and work instructions for new/modified designs.
Establishes and maintains an ISO quality document control system for all engineering drawings and related information.
Train operators as required in the use of tools, fixtures and processes.
[*] Quality Improvement Process:
Design controls to ensure compliance with FDA QSR and EN 13485 regulatory requirements.
Support regulatory and agency regarding control and assessment of product design and manufacturing quality.
Participate in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
Implement Design Requests from Customer:
Consider the cost factors of design and manufacturing methods applying along with industry standards and sound engineering principles to produce a robustly engineered product.
Demonstrated Experience in the following areas will position you as the ideal candidate:
Mechanical design experience required; medical manufacturing experience preferred
Six Sigma Green or Black belt experience preferred
Competence in the selection and use of Engineering Tools and Techniques.
Good knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, UL, CSA, VDE, etc.)
[*] Qualified Candidates must be able to demonstrate the following:
Bachelors Degree in Mechanical Engineering5+ years’ work experience or equivalent experience in related industry.
Proficient in parametric 3D CAD design. (SolidWorks, Inventor a plus)
Exceptional Proficiency with Microsoft Office
Ability to work independently and in team environment.
Ability to effectively communicate written and verbally.
Analytical skills and problem solving capacities. A drive to improve performance.