Manufacturing Engineer - Medical Devices
Posted on Aug 14, 2019 by TE Connectivity
TE's Medical business unit, part of the Industrial Solutions segment, offers medical device OEMs, a complete product offering, and capability portfolio for minimally invasive, imaging, surgical, diagnostic, and therapeutic devices. With more than 350 design engineers and a global presence in all key medical device hubs, we are a premier partner to the world's leading medical technology companies for their next-generation medical devices. We are experts in all aspects of device design and manufacture, from access & delivery solutions for interventional medicine; to sensors & connectors for surgical applications. Our innovative solutions enable ground breaking medical therapies such as treating heart disease without opening the body, placing microscopic devices into brain arteries and powering robotic surgery.
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.
Responsibilities & Qualifications
The Manufacturing and Process Development Engineer is responsible for providing engineering knowledge, skill, and ability to handle such tasks as: project management, engineering design, prototyping development, gathering of pertinent background information, and leading project and design teams from conception through commercial launch of medical devices.
- Initiate process innovation, process development and improvement in terms of cost reduction and increase efficiencies on the product line.
- Coordinate production operations with the requirements for finished products and the need for materials and labor.
- Performs, demonstrates, and trains new employees on all pertinent manufacturing processes and quality requirements.
- Provide technical leadership in the areas assigned and provide "Design for Manufacturing" input to R&D, customers, and product commercialization teams.
- Design and implement new tooling, fixturing, and capital equipment.
- Writes all essential documents (i.e. MPI's, Inspection Plans, LHR's, DMR's, Validation Processes, and Calibration /PM Requirements).
- Work closely with R&D Engineering group to assist and coordinate project transfers from R&D phase to Manufacturing phase.
- Will be responsible for establishing product requirements, concept prototyping, design and development (including verification and validation), risk/failure mode assessment, performance and safety testing.
- Maintains detailed documentation throughout all phases of manufacturing development and transfer phases.
- Reviews or coordinates outside vendor activities to support development.
- Interface with customers and internal departments articulating team activities and progress.
- B.S. in Mechanical Engineering or Bachelor's Degree
- A minimum of four (4) years' work experience in a related regulated medical device environment.
- Values: Integrity, Accountability,Teamwork, Innovation