The Opportunity

This position works out of our Plymouth location in the Structural Heart division. Structural Heart Business Mission: why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. This position will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality. What You’ll Work On Manage projects which include new production equipment, process improvements and cost reductions while supporting new product introductions. Provide guidance to other engineers and technicians. Additional responsibilities include: Provide technical mentorship and leadership to engineers and technicians Coordinate with cross functional teams to resolve production related issues Conduct Process FMEAs and Process Validations Improve product quality, labor efficiency, and throughput through the use of Lean manufacturing concepts Coordinate the design, procurement, build and debug of tooling, machinery and test equipment Work with Product Development to ensure Design for Manufacturability Individual should: Be innovative, resourceful, and work with minimal direction; have excellent organization, problem solving, communication, and team leadership skills; work effectively with cross-functional teams 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. Required Qualifications Bachelors Degree (± 16 years) Mechanical, Biomedical, Chemical or any engineering or technical degree or an equivalent combination of education and work experience. Minimum 5 years of manufacturing engineering experience, medical device experience required. Strong analytical, problem solving and project management skills. Six Sigma black belt or green belt certification preferred. Demonstrated leadership capability in team settings. 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. Preferred Qualifications Six Sigma certification. Experience working in a broader enterprise/cross-division business unit model. *