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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Technical Operations Manager


Reference:JCAO30320 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Principal Engineer, Process Development Engineer, Project Engineer

Technical Operations Manager



Our client a high potential start up medical device company currently seeks a Technical Operations Manager to join their team. Reporting to the COO the Technical Operations Manager will be responsible for all technical aspects of product manufacturing from transfer of the design to manufacture, oversight of sub-contract manufacturing organizations and process improvements.



Role and responsibilities:

• Oversight of the transfer of the device design (and related controls) from the design phase to routine manufacturing

• Managing the supply chain including the sub-contract manufacturing organizations, key component suppliers and the sterilization facility

• Responsibility for the distribution of devices to support clinical activities

• Managing key suppliers to assure reliability of supply, quality of product, process validation, optimization of manufacturing processes and process reliability

• Inventory control management based on demand plan- clinical and R&D

• Identification and implementation of manufacturing arrangements for next generation devices • Inventory control and operational planning to ensure delivery of product in line with the company’s business plan

• Set and manage budgets and COGs for product supply

• Negotiation of agreements and contracts with key suppliers (with COO/ CEO)

• Support CEO, COO and CTO in execution of the company’s technical plan


Skills/Experience:

• Bachelor degree in science, engineering or related field

• Proven track record in a similar role with a minimum of 5 years in medical devices industry

• Knowledge of quality management systems, design controls per ISO 13485 and current International and European regulations/standards with respect to medical devices.

• Experience in design, verification, and process validation processes

• Prior experience with implantables highly preferred

• Prior experience with sub contract manufacturing arrangements preferred

• Excellent verbal and written communication skills

For further information please contact James Cassidy [email protected] or call in confidence 086 0204322