At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview

Diagnoses problems and performs maintenance of complex equipment; ensures specific manufacturing behaviors are in line with practice and operation standards.

Job Requirements Compiles systematic diagrams or reports on manufacturing procedures and results, facility utilization, failure summaries, etc. and advises on process optimization. Participates in and monitors manufacturing processes; implements appropriate operation standards and follows production regulations. Reschedules manufacturing tasks among technicians to cope with requirement variances. Guides junior technicians on how to operate and maintain equipment, and provides further training, as necessary. What your background should look like

Key Responsibilities:

 

New Product/Process Development Execute process and test method validation along with design, develop, and qualify tooling/equipment Using problem solving and DMAIC tools to solve processes and process improvements New Product Introductions Manage product transfers from new product development to operations or product transfers from site to site.   Develop bills of materials and assembly methods documentation while providing any training needed to technicians and assemblers. Team Leadership (Primary) An effective communicator that prepares status reports, modifies schedules, and manages project plans.   Communicate to stakeholders, customers, and others informed of project status and/or related issues Ability to coordinate a team of engineers and technicians and direct technical work Coach/mentor technical topics to junior engineers and technicians during product transfers Collaborate effectively with other departments, including Quality, R&D, NPD, and Operations. Project Management (Supporting) Manage your project timelines and resources effectively. Work with cross functional teams while being self-driven Manage activities with risk to the project timelines, developing contingency plans, while outlining deliverables and milestones Quality, Safety and Regulatory Compliance (Supporting) Work with Quality Team to ensure all manufacturing processes and equipment comply with FDA regulations, ISO standards, and other relevant industry guidelines Comply with safety and security procedures and report potentially unsafe conditions when using equipment and materials properly Manage design requirements like Bioburden or Particulates, Biocompatibility and Cleanroom Environment compatibility

Required Skills & Experience

 

Bachelor's degree in Engineering, Plastics, Chemical, Biomedical or Mechanical Engineering preferred 2+ years of working experience in the Medical Device Industry Thorough understanding of Quality Management Systems (QMS) requirements that involve: Process Mapping Manufacturing Process Instructions DOE and Process Characterization OQ/PQ Protocol and Reports IQ/OQ Protocols and Reports PFMEAs MVP/MVRs. Experience in technically leading a team of engineers and technicians across multiple projects Medical Device New Product Development which includes process development and characterization along with equipment/fixture design and qualification and test method and process validations Preferred Skills & Experience Hands-on experience with complex steerable or multi-lumen catheter assembly development and manufacturing with that includes manufacturing technologies with mandrel design, PTFE assembly, reflow, braiding, tipping and extrusion Experience with design controls, FDA regulation, GMP practices, and QSR requirements CAD proficiency - SolidWorks and Mastercam MS Office proficiency  Experience in: Arena / Flex Sim Ability to achieve goals with effective planning and prioritization skills to meet immediate and long-range needs with independence Must be well-organized, detail-oriented, with excellent oral and written communication skill Yellow Belt (desirable) American Visa (desirable) Power BI (desirable) Competencies Values: Integrity, Accountability, Inclusion, Innovation, Teamwork