Our client is an early stage, dynamic med-tech company.  Harty Search & Selection have been retained to strengthen their management team by sourcing suitable candidates for the position of Technical Operations Manager.   The newly appointed person will be a key member of the senior management team, playing the lead role in establishing in-house and 3rd-party manufacturing capability and driving NPI and commercialisation for a new structural heart device.

Primary Responsibilities: 

• Working as a part of a close-knit, cross-functional team to implement manufacturing processes and specifications for production of a new innovative med-tech device (heart).
• Develop and update documentation relating to equipment or processes to manufacture the device in a controlled manner in line with Regulatory standards, e.g specifications, BOM, DHR, DMR, validation documents, etc.
• Adhere to GMP best practices based Quality Systems requirements for medical devices including ISO 13485.
• Process development and characterisation including PFMEA.
• Lead cross functional teams to assess and qualify suppliers to ensure a robust supply chain.
• Ensure product quality requirements are met both internally and throughout the supply chain during product manufacturing.
• Ensuring adherence to all organisational and external regulatory requirements.

Skills, Qualifications & Experience:

• Degree or Masters degree in engineering, or related disciplines.
• Comfortable in a start-up business, can adapt (in the absence of previous experience) to a small company environment.
• Minimum of ten (10) years of medical device experience in new product introduction, manufacturing, quality or project engineering, preferably in cardiovascular devices.
• Project management skills.
• Ability to manage self and others to achieve challenging targets.
• Demonstrated analytical problem-solving abilities to resolve complex technical issues.
• Class III medical product development experience is preferred.
• Working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
• Experience of preparing technical documentation.
• Leadership qualities.

All enquiries can be made in total confidence by contacting Liam McDonnell on +353 61 414533