Job Description :
Job Summary:
· This position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality.

Responsibilities:
· Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality
· Evaluation of production equipment
· Production support and process validation, including TMV
· Interface with vendors for incoming components
· Troubleshoot manufacturing process and equipment
· Utilize tools like Gage R&R, Cp, Cpk, and SPC to improve processes
· Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
· Protocol and report writing
· Generate and modify manufacturing process documentation
· Work with cross functional teams as required
· Develop and implement process improvements
· Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
· Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
· Performs other related duties and responsibilities, on occasion, as assigned.



General Qualifications:
· Mechanical, Industrial, Chemical, Biomedical, etc. Engineering degree required.
· Previous medical device experience required.
· Experience working in a broader enterprise/cross-division business unit model preferred.
· Ability to work in a highly matrixed and geographically diverse business environment.
· Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
· Ability to leverage and/or engage others to accomplish projects.
· Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
· Multitasks, prioritizes and meets deadlines in timely manner.
· Strong organizational and follow-up skills, as well as attention to detail.
· Ability to travel approximately 25%, including internationally.
· Ability to maintain regular and predictable attendance.