R&D/Product Development Engineer II

Function:  ENG & TECH - R&D/PRODUCT DEVELOPMENT ENGINEERING
Requisition ID:  20350
Location:  San Jose, CA, US, 95131
Alternative Locations: 
Education Experience:  Bachelors Degree (High School +4 years)
Employment Experience:  1-3 years
Travel:  10% to 25%

 

Company Information

TE Connectivity Ltd., is a $13 billion global technology and manufacturing leader creating a safer, sustainable, productive, and connected future. For more than 75 years, our connectivity and sensor solutions, proven in the harshest environments, have enabled advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With 78,000 employees, including more than 7,000 engineers, working alongside customers in nearly 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedInFacebookWeChat and Twitter.

 

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.

 

 

Job Overview

TE Connectivity’s R&D/Product Development Engineering Teams conceive original ideas for new products, introduce them into practice. They are responsible for product development, and qualification from market definition through production and release; assist in the qualification of suppliers for new products to ensure suppliers deliver quality parts, materials, and services for new or improved manufacturing processes; conduct feasibility studies, testing on new and modified designs; direct and support detailed design, testing, prototype fabrication and manufacturing ramp. The R&D/Product Development Engineering Teams provide all required product documentation including, but not limited to, Solid Model, 2D/3D production drawings, product specifications, and testing requirements. They create and modify detailed drawings and drafting or conceptual models from layouts, rough sketches or notes and contribute to design modifications to facilitate manufacturing operation or quality of product. Typical fields of expertise include: materials, mechanics and systems, electrical, optics, chemistry, software, automation systems, packaging, testing and measurement, and manufacturing of electrical, mechanical and electronic components, products, and their integration into systems.

Responsibilities & Qualifications

Responsible for the development and introduction of new medical interventional products. The RD/PD/DS Engineer will champion the execution of new products that deliver an exceptional customer experience. Additionally, the RD/PD/DS Engineer will be responsible for managing project costs, issuing quotes to customers, procuring material quotes, interacting with customers while ensuring full compliance to FDA QSR (21 CFR 820), and applicable ISO 13485 requirements. Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation.


Be an integral part of the team tasked with the development process from concept generation through to device design and development.

  • Liaise with the development teams to provide direction and advice on device assembly challenges.
  • Create new design solutions or leverage existing designs to create cost effective and efficient improvements to assembly challenges.
  • Develop fully detailed Specifications for tooling and fixturing according to company quality standards.
  • Communicate and manage manufacture of fixturing with tooling manufacturers.
  • Design and develop new medical products to meet customer requirements within scope (e.g., performance and quality), schedule (e.g., on time delivery), and budget (e.g., price) constraints.
  • Conduct FMEA (Failure Mode Effects Analysis) and risk analysis reviews on NPI (New Product Introduction) products.
  • Support the maintenance of specifications and other relevant documentation to comply with quality standards.
  • Contribute to Product design activities
  • Assist in the development of intellectual property generated by development activities.

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • A Mechanical Engineering or equivalent degree.
  • A high skill level using Solidworks 3D modeling software.
  • 1 to 3 years in a mechanical design environment preferably in a medical device design environment, with exposure to product design and Fixture design.
  • A working Knowledge of minimally invasive Medical Device design, development and manufacturing processes.
  • The ideal candidate will have skills in tooling and jig and Fixture design. Demonstrated aptitude of innovative mechanical design skills including but not limited to frequent use of 2D and 3D CAD (Pro/Engineer) modeling, GD&T, and prototype creation.
  • Demonstrated excellent written and oral communication skills.
  • Must have relevant experience working with project teams in planning and executing project plans and delivering projects through key milestone phases and associated activities.
  • Experience of participating in Design Reviews and the compilation of associated documentation, including:
    • A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements.
    • Experience in working with teams on compilation of FMEA, design verification and validations protocols and reports and Design History File requirements

Competencies

  • Values: Integrity, Accountability,Teamwork, Innovation


Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto

Job Segment: Developer, R&D Engineer, Manufacturing Engineer, Engineer, Electrical, Technology, Engineering

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