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.
- 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