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.
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