Teva MS & Senior Manager- Medical Devices 

Ireland 

638765654

You’ll be working closely with the R&D Device Teams within Teva along with the commercial manufacturing sites to manage and support the industrialization of devices and combination products to enable successful on-time product launches.

You’ll be collaborating with groups to ensure robust device designs are developed for future commercial scale including molding and pre-assembly stages, final assembly, QC activities (incoming and outgoing parts) and device assembly processes for industrialization ensuring that knowledge and expertise is transferred successfully from R&D to the commercial manufacturing site. It will include working with R&D in the early stages of device development to assess Design for Manufacture & Assembly to ensure that the device is considered approvable from a performance and equivalence perspective and is scalable for commercial manufacturing.

Key Responsibilities:

• Support Global R&D device and combination product development activities.
• Manage the industrialization activities of devices and combination products.
• Manage and support training and knowledge share with Teva manufacturing sites.
• Identification and assessment of potential new device platforms and manufacturing technologies appropriate for the current and future pipeline.
• Support due diligence activities as required.

This position could be based from any one of three sites:

• Waterford, Ireland

• Runcorn, England

• Zagreb, Croatia

Travel Requirements:

• The job will require up to 10-30% of your time out of office

• Degree in Engineering, Physics or similar

  • Post-Graduate Education in either Product Development, Business, Manufacturing, Medical Device Regulations would be preferred

Required career experience:

• Knowledge of Device Quality Management Systems in accordance with ISO13485 and 21CFR 820

• Experience of managing Device Development Projects, ideally from concept to launch

• Understanding of device development and manufacturing processes

• Knowledge of primary packaging, filling and assembly

• Understanding of device design and assembly including tooling development and manufacturing processes

Preferred but not essential career experience:

• Experience of working with Device vendors and OEM’s

• Knowledge of the regulatory requirements for devices and combination products within the US and EU, including the compilation of Design History Files and Design Master Records

• Sterile product development knowledge (through experience)

Are you?

• Action oriented and full of energy for the tasks you see as challenging

• Able to effectively cope/manage with change

• Someone who enjoys leading; takes unpopular stands if necessary; encourages direct and tough debate; is looked to for direction in a crisis; faces adversity head on

• Able to adhere to an appropriate (for the setting) and effective set of core values and beliefs

• Understanding of the importance of team collaboration

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