Senior R&D Engineer Senior R&D Engineer

TE Connectivity (Galway, Ireland) 28 days ago

About TE Connectivity

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 


TE Connectivity is a $12 billion global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With nearly 80,000 employees, including more than 8,000 engineers, working alongside customers in approximately 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn , Facebook , WeChat and Twitter .

Creganna Medical is ranked among the top 10 global companies in the medical device outsourcing industry. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Serving over 400 companies across 30 countries, Creganna Medical’s customers include the world’s leading medical device and life science companies. Headquartered in Galway, Ireland, Creganna Medical has a global operational footprint with design and manufacturing facilities spanning the U.S., South America, Europe and Asia. http://www.creganna.com/

Job Overview

As part of the R&D Engineering team at our Parkmore facility, the Senior R&D Engineer will lead and be an integral part of a team developing Creganna's portfolio of platform delivery system products. This position requires a candidate with significant product development experience in the medical device arena and one who will be comfortable leading and developing a team to develop Creganna’s products.  They will report to the Group Leader, and the position will be based in our Parkmore facility. 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.

Job Responsibilities
  • Lead and be an integral part of the team tasked with the development process from concept generation through to design verification. 
  • Assist in the development of intellectual property generated by development activities.
  • Ensure the application of new and existing technologies to provide the optimum delivery system design.
  • Participate in trials with physicians to provide clinically relevant feedback on product designs. 
  • Provide technical feedback during frequent technical contact with customers to optimise product design. 
  • Support the maintenance of product files and other relevant documentation to comply with quality standards.
  • Compile project plans and lead team to develop devices in accordance with planned activities, budget and timelines.
    What your background should look like:

    Key Requirements

    • Experience in coordinating and leading Design Reviews and the compilation of associated documentation.
    • Leading the team to carry out actions in accordance with the project plan and deliver projects through key milestone phases and associated activities.  
    • Demonstrate a thorough knowledge and understanding of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements. 
    • Proven experience of minimally invasive Medical Device design, development and manufacturing. 
    • Proven experience in leading teams performing FMEA’s, verifications and validations for medical devices products and processes. Knowledge and experience with Medical Device sterilisation processes, specifically gamma and EtO sterilisation.
    • Proven experience of work with catheter technology, catheter design and testing and catheter manufacturing a distinct advantage. 
    • Experience with engineering tools such as DOE, SPC, and using Minitab.
    • 3D modelling experience.
    • Working knowledge of biocompatible metal and/or polymer materials.
    • Demonstrate a working knowledge of the required activities and deliverables from each of the development phases.  
    • Availability to participate in limited travelling to meet with customers to conduct scheduled reviews.

    Qualifications

    • Level 8 engineering, science or equivalent degree.  
    • 5 to 8 year’s industry experience in a medical product development environment with a proven track record of leading teams in device development.

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    Competencies
    Values: Integrity, Accountability,Teamwork, Innovation

    What TE Connectivity offers:

    We offer competitive rewards & compensation. Our commitment to our employees includes offering benefit programs that are comprehensive, competitive and will meet the needs of our employees.

    • Competitive Salary Package
    • Performance-Based Bonus Plans
    • Health and Wellness Incentives
    • Employee Stock Purchase Program
    • Community Outreach Programs / Charity Events
    • Employee Resource Groups

    Senior R&D Engineer Senior R&D Engineer

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