Europlaz Technologies is a leading contract medical device manufacturer

Europlaz Technologies leading contract medical device manufacturer

Mechanical Production Engineer

We are recruiting an experienced Mechanical/Production Engineer to work for a leading contract Medical Devices organisation specialising in sterile and non-sterile medical device design, development and manufacture. Products include Drug Delivery systems, Neonatal Critical Care devices, Respiratory Device Development and General Surgical Device & Accessory Development.

Are you an engineer who enjoys a hands on challenge or problem to solve? Can you also maintain excellent records and work to the requirements of ISO 13485 and FDA device history files?

This is a varied and interesting role working as part of a small, skilled team on state of the art innovations in the medical device field. This company partners closely with a diverse customer base, from large pharma to start up companies in the UK.

Key responsibilities:

Participate in medical device projects and provide project leadership on medical device development projects with primary mechanical design and production transfer responsibilities

Create transfer to manufacturing documentation, including requirements, specifications and process documentation (instructions, procedures, BOMs, etc.

Provide support for design verification and validation

Maintain project schedule by monitoring project progress; coordinating activities; resolving problems.

Control project plan by reviewing design, specifications, and plan and schedule changes; recommending actions.

Define and execute process qualification and all documents (PFMEA, PVP, IQ, OQ, PQ,)

Preferred Knowledge, Skills, and Abilities

 

  • Demonstrated technical knowledge of mechanical part design and manufacturing, including thermoplastic materials, the related tooling and injection molding and other related process technologies.
  • Experience establishing and validating production lines.
  • Ideally we need someone with hands on production installation, commissioning and validation (IQ, OQ and PQ), experience.
  • Proficient in Microsoft Office; Word, Excel, Access, Visio and Outlook
  • Knowledge of Solidworks
  • Experience applying statistical analysis using analytical packages (MiniTab, Mathmatica, etc)
  • Strong technical writing skills
  • Training will be provided

 

Benefits

 

  • Annual pay review
  • Career progression and development
  • Ongoing training
  • Company incentives / bonus
  • Free parking
  • Strong transport links - just one hour by train from London Liverpool Street.

 


For further information please email your CV to Lynn.watkinson@europlaz.co.uk or call 01621773471.