Job Overview

TE Connectivity's R&D and Process Development Engineering Teams significantly drives New Product Development (NPD) initiatives through product/process development projects within existing or new manufacturing technologies.  This role is a critical element between product/process development and operations to ensure effective transition. This position requires a blend of technical expertise, leadership skills, project management, and innovative thinking to drive manufacturing excellence and process optimization.  The location for this position will be at San Rafael, Costa Rica.

Job Requirements

•New Product/Process Development
o Execute process and test method validation along with design, develop, and qualify tooling/equipment
o Using problem solving and DMAIC tools to solve processes and process improvements

•New Product Introductions
o Support product transfers from new product development to operations or product transfers from site to site.  
o Support bills of materials and assembly method documentation while providing any training needed to technicians and assemblers.

•NPD Team Member (Primary)
o A good communicator that works effectively with key stakeholders
o Supports timelines while working independently to executing critical activities
o Collaborate effectively with other departments, including Quality, R&D, NPD, and Operations.

•Project Activity (Supporting)
o Manage project timelines and resources effectively.
o Work with cross functional teams while being self-driven
o Manage activities with risk to the project timelines, developing contingency plans, while outlining deliverables and milestones

•Quality, Safety and Regulatory Compliance (Supporting)
o Work with Quality Team to ensure all manufacturing processes and equipment comply with FDA regulations, ISO standards, and other relevant industry guidelines
o Comply with safety and security procedures and report potentially unsafe conditions when using equipment and materials properly
o Manage design requirements like Bioburden or Particulates, Biocompatibility and Cleanroom Environment compatibility

What your background should look like

•Required Skills & Experienceo Bachelor's degree in Engineering, Plastics, Chemical, Biomedical or Mechanical Engineering preferred
o 3 to 5 years of engineering experience
o 1 to 3 years of working experience in the Medical Device Industry 
o Working experience in new production development or product transfers
o Experience with 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.
o Experience working in a team of engineers and technicians across multiple projects
o 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
o 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 
o Experience with design controls, FDA regulation, GMP practices, and QSR requirements
o CAD proficiency - SolidWorks and Mastercam
o MS Office proficiency  
o Ability to achieve goals with effective planning and prioritization skills to meet immediate and long-range needs with independence
o Must be well-organized, detail-oriented, with excellent oral and written communication skills

Competencies