Manufacturing Engineering Leader OmniGuide
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This position will significantly improve OmniGuide?s manufacturing processes by implementing best practices in process control, quality control and reliability engineering. In addition, the successful candidate will play a major role in improving the New Product Development transfer process by implementing design for manufacturability, design for assembly, and design for reliability as a member of a new product development team. This position will report to the VP of Operations and will not have direct reports, initially. This position will act as a technical lead person and liaison between R&D- Engineering, Manufacturing and QA/RA in product/process development projects and teams. As the position matures, objectives are accomplished and the business grows, the Mfg/Reliability Engineering team will expand and direct reports may be added as required.
Define and execute process improvement projects in both upstream and downstream operations that particularly target process capability improvements.
Perform process and equipment troubleshooting on a routine basis.
Implement quality control best practices, including SPC, throughout the plant.
Ensure Manufacturing?s regulatory compliance with all applicable agencies.
Improve and oversee Manufacturing?s validation and verification processes.
Participate in NPD core teams focusing on smoothly transitioning new products with capable processes into Manufacturing.
This position is for an exceptional professional engineering leader with the right and rare combination of the following abilities, behaviors and competences:
Ability to effectively communicate at all levels of the organization in a clear, complete and concise manner.
Ability to influence without direct authority ? by leading and guiding by personal example.
Solid engineering education in industrial, manufacturing and/or mechanical engineering. Undergraduate and graduate degrees in an engineering discipline are preferred.
5-7 years of hands-on experience in industrial / manufacturing process design in medical devices- including but not limited to process implementation, validation, operation, maintenance and improvement.
At least (5) years of experience in verification and validation of new product launches, product/process line transfers, pilot plants and new mfg. process development.
Cambridge, Massachusetts, United States
||One Kendall Square, Building 100 |
Cambridge, MA 02139
THIS JOB HAS EXPIRED