SR MFG & PROCESS DVL ENGINEER

Job Overview

TE Connectivity's Manufacturing and Process Development Engineering Teams significantly impact LEANPD driven new product development projects, driving for excellence in existing manufacturing technologies and methods and striving to implement new manufacturing technologies to provide improved process and tolerance control. They act as the binding element between product development and manufacturing engineering, ensuring the effectiveness and efficiency of this critical interface. They support Product Development in the optimization of designs and piece parts for manufacturability by realizing sample tooling/products/prototypes. They also design, develop, and qualify tooling and processes to meet TE quality and production standards, document all processes and tooling in applicable TE systems, support supply chain to verify supplier compliance and capability, initiate and implement programs to continuously improve quality, cost and cycle time and adhere to all appropriate specifications, regulatory requirements and customer requirements.

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
• 7+ years of working experience in the Medical Device Industry
• 3+ years of working experience in new production development or product transfers
• 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  
• 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
• Black Belt (preferred)

Competencies