Product Design and Development Engineer - Medical Devices

Job Overview

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 groundbreaking medical therapies such as treating heart disease without opening the body, placing microscopic devices into brain arteries, and powering robotic surgery.

Job Requirements

• Work with global multi-functional project teams to support on technical and SAP documentation
• Strong background in product design, development, and sustenance engineering
• Manage sustenance engineering tasks for medical products and related documentation
• Hands-on experience with Design Control processes, including Verification & Validation (V&V)
• Proficient in engineering tools and systems such as SAP, PLM/PDM, Creo, and SolidWorks, with solid experience in Engineering Change Management (ECM) activities
• Understand the functional requirements of a product and ensure that the design changes meet the functional requirement
• Review and understand BOMs, routers and Inspection Plans/ROS according to requirements
• Work on trails data, carryout statistical analysis, and reports
• Creating technical documentations as per change requests and prompt response
• Deliver required documents as part of phase gate deliverables
• Look for the opportunities of improvement and implement process improvement ideas.
• Properly document and internally communicate all technical discoveries, inventions, and intellectual property.  Maintain confidential and proprietary information and communications as property of TE
• Continuous Improvement: Identify and work with key business stakeholders and operations teams to implement improvement opportunities using Lean and six-sigma tools.
• Service: Ensures that Exceptional Customer Experience (ECE) for both the Internal and External customers are met by meeting or exceeding commitments.
• Responsible for managing the overall equipment performance (OEE) through the appropriate use of Lean Manufacturing tools and techniques (TPM etc.)
• Ensure equipment preventative maintenance procedures are effective and ensure compliance to preventative maintenance program.
• Introduction of new equipment; equipment installation validation, process development and validation.
• Resolve quality and technical issues such that impact on product supply to customers is minimized and support Business Unit CAPAs, NCs, FMEAs and audit prep activities.
• Develop and manage SOPs / manufacturing standards / operations standard work as required in compliance with change control process.

What your background should look like

• Bachelor’s in engineering (Mechanical), M.S. in Engineering a plus.
• Demonstrated product development experience

Critical Experience

• Bachelor’s degree in mechanical engineering with Minimum five or more years of related medical product design and development engineering experience.
• Strong background in product design, development, and sustenance engineering
• Hands-on experience with Design Control processes, including Verification & Validation (V&V)
• Proficient in engineering tools and systems such as SAP, Creo, and SolidWorks, with solid experience in Engineering Change Management (ECM) activities
• Good understanding of automation concepts and their application in engineering solutions
• Excellent written and verbal communication skills, with the ability to collaborate effectively across cross-functional teams
• Hands-on experience in NC handling and CAPA processes
• Well versed with product lifecycle management process.
• Hands-on experience in SAP (PLM experience) to Review and understand BOMs, routers and Inspection Plans/ROS according to requirements
• Hands on experience in VAVE / CoPQ (Cost of Poor quality)
• Fixture design and development knowledge
• Demonstrate a practical understanding of Lean Manufacturing principles and statistics.

Competencies

• Innovative mechanical design skills.
• Can-do attitude, resourceful, action oriented, and drive for results.
• Good problem solving and project management skills.
• Ability to effectively manage and motivate others to meet deadlines.
• Networks with key contacts outside own area of expertise and experience working with overseas suppliers/customers.  Willing to travel globally if needed.
• Demonstrated excellent written and oral communication skills in English language

Competencies