- Coordination and project management of medical device and package development products.
- Develop and use best practices for injection molded part design, mold tooling design and design for assembly principles and techniques.
- Create, review and approve technical part drawings by using 3D CAD software to facilitate effective tool designs including gating, cooling, ejection and shrinkage allowances.
- Review and assess factors that affect design decisions such as manufacturing equipment, material selection, part tolerances, product usage and cost.
- Assist in the implementation of engineering DFMEA's and design review documentation.
- Complete assigned projects on time and on cost that meets or exceeds customer expectations internal and external.
- Work with suppliers, mold makers, Product Development and other departments to resolve design development, manufacturing, quality and service issues.
- Foster close cooperative relationships with all functions in the company and with external international suppliers and manufacturers.
- Work closely with Strategic Sourcing and Quality to evaluate the capabilities of potential contract manufacturers and assist with/approve validation activities
- Refine and enforce policies with particular emphasis on compliance to the company's Quality System and external regulatory standards including ISO 13485 and FDA regulations
- Bachelor of Science degree in Engineering from accredited university or college in Packaging or Mechanical Engineering and/or related field preferred
- Minimum 5 years in design, mold making, injection molding and plastic production experience within a consumer products organization – FDA regulated industry preferred
- Knowledge and understanding of the FDA guidance for Medical Device Design and ISO 13485 Standard
- Ability to lead technical exploration and provide technical advice to both internal and external associates
- Ability to identify, problem solve and interpret complex engineering problems
- High proficiency in computer skills including Microsoft Office, Excel, Word, Solidworks and Adobe Illustrator
- Proven ability to work successfully in cross functional teams
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