Job ID: 238297084
Are you ready to take the next step forward in your career?
Would working independently on a variety of different mechanical projects appeal to you?
Would you enjoy working with Client’s in a variety of different industries?
Our Cincinnati headquartered Product Design and Manufacturing Services Client takes product ideas and dreams and turns them into reality. They manage every step in the product’s development process from design to manufacturing and marketplace delivery.
Some of the industries that have turned to our Client for help are:
- Medical and Rescue
- Automotive Components
- Appliance and Electric Motor Components
- Consumer Products
- General Industrial Components
Our Client is seeking a Senior Mechanical Project Engineer to join their Manufacturing Consulting Team. Take a closer look.
Your Roles and Responsibilities
- Create all materials required to manufacture products according the customer’s design specifications including but not limited to CAD files and technical specifications
- Manage Client and Contract Manufacturer relationships to ensure the mutual satisfaction of both parties.
- Record, investigate, analyze and determine corrective and preventive actions that must be taken to ensure customer satisfaction.
- Perform or assist in performing customer training activities related to quality systems and product quality.
Contract Manufacturer Relationship Management
- Evaluate and recommend sources for production to include product, required tooling and/or secondary manufacturing or operational services.
- Continuously work with contract manufacturers to assure good, consistent quality production.
- Analyze and evaluate information concerning manufacturing challenges, take corrective and preventive actions including addressing quality system concerns.
- Participate actively in manufacturing inspection and testing activities to ensure continuous control over materials, facilities, and products.
- Generate documentation to ensure compliance with FDA Medical Device Regulations including the current Good Manufacturing Practice (cGMP), ISO 13485, European regulatory requirements (Medical Device Directive (MDD) and other general manufacturing compliance directives and regulations.
- Ensure compliance with standards and regulations established by the company or relevant regulatory bodies
Technical Record Keeping
- Maintain all device master records and technical files to comply with applicable regulatory and ISO requirements.
Your Professional Experience
Core Mechanical Design and Engineering Skills
Must possess the ability to:
- Read and interpret technical drawings, either hard copy or electronic in commonly used electronic engineering formats and interface with customer’s similar programs.
- Create a technical drawing electronically and all necessary data that can be used for the production facility to manufacture products.
- Define problems, collect data, establish facts, and draw valid conclusions.
- 'Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Mechanical Design, General Engineering and Manufacturing Experience
- 8 plus years of mechanical design experience working with metals, plastics or both.
- Preferred experience includes ISO 9001 or ISO 13485 or both, Medical Device Directive (MDD) and Good Manufacturing Practice (cGMP).
- Able to work independently in an entrepreneurial culture and environment.
- Plan, manage and coordinate multiple ongoing Client projects.
- Manage and maintain technical files that support each project.
General Business Experience
- Solid interpersonal skills and the capability to work one-on-one with clients on their products and projects.
- Hands-on experience identifying, selecting and managing relationships with contract manufacturers.
Your Educational Background
- Bachelor’s degree: Mechanical or Mechanical Design Engineering
- SolidWorks; PMP / CSSGB / CSSBB certification preferred.
Travel Required: Position requires up to 25% travel both domestic and international to China and Europe
Benefits: Highly competitive including fully paid health insurance, 401K match, Sickness and Disability Insurance as well as paid time off.