Senior Production Engineer (Ventricular Assist Devices)

Location
Swansea
Salary
£60,000 per annum
Posted
07 Nov 2016
Closes
08 Dec 2016
Ref
225078523-01
Contact
Sue Bithell
Contract Type
Permanent
Hours
Full Time

Calon Cardio-Technology Ltd

Senior Production Engineer (Ventricular Assist Devices)

The position is:

  • A permanent full time post
  • 40 hours per week
  • £60,000 per annum
  • Location - Swansea, UK

Calon Cardio-Technology Ltd
Calon is a Swansea-based company developing a heart pump to be directly implanted into a failing heart.

Job Description:

  • To assume responsibility for all production activities at Calon.
  • To establish and manage Calon’s assembly facility, and the processes specifically required by the specialized field of permanently implanted mechanical cardiac assist systems.
  • To assure that the product manufacturing objectives of Calon are clearly documented, including timelines, and accurately communicated to the company’s CEO.

Qualifications:

  • Mechanical Engineering (Bioengineering) Degree from a recognized engineering program at a University in the EU or USA
  • 3 years’ direct experience of permanent Ventricular Assist Device (VAD) manufacturing processes with emphasis on new product development
  • 3 years’ direct experience of implantable medical device (or Class 3 Medical Device) manufacturing under a Quality Management System.

Skills:
Manufacturing processes, including but not limited to:

  • CNC milling and turning, EDM
  • Injection molding
  • Laser welding, etching, and additive machining
  • Mechanical and electrical assembly procedures and techniques
  • Adhesives and bonding, polishing, diffusion bonding

Cleanroom requirements (Class 5, Class 7, and Class 8):

  • Installation, operational and performance qualification
  • FDA compliant environmental management Cleanroom procedures and maintenance (including cleaning)

Technical writing
Manufacturing and Safety standards including:

ISO 13485, ISO 14971, ISO 14644, IEC 60601, FDA 21CFR, AIMDD

Software applications:
CAD and FEA (SolidWorks), MS Office, including Excel and MS Project, SQL, Photoshop, LabVIEW

How to apply
Please e-mail detailed CV to Sue Bithell by following the instructions at the bottom of this page.

Closing date will be 8th December 2016