Technical Operations Manager

Opportunity

A medical device start-up looking to hire a Senior Engineer in New Product Introduction who will support the manufacturing of a cutting edge structural heart device through design development, verification, clinical trials, validation and regulatory approval. This role will provide technical engineering leadership to meet objectives in new product introduction, product commercialization and supplier projects. This position offers the opportunity to join an exciting early stage company.

Role and responsibilities:

  • Working as a part of a crossfunctional team to implement the manufacturing environment and processes for production of a novel transcatheter heart repair device in line with specifications.
  • Takes the lead on all manufacturing activities from cleanroom management, supplier qualification, internal equipment and process controls, packaging and sterilization.
  • Planning, implementing and co-ordination of manufacturing to include: specifications, process development, training, production procedures, material specifications,and procurement.
  • Develop and update documentation relating to equipment or processes to manaufacture the device in a controlled manner in line with Regulatory standards, e.g specifications, BOM, DHR, DMR, validation documents, etc.
  • Development of manufacturing processes in conjunction with R&D including, as required, training of technicians and process operators
  • Sourcing and implementing tooling, equipment and technologies, as required to implement the manufacture of the device.
  • 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.
  • Support quality related activities for device manufacturing ensuring controls are implemented and maintained (inspection standards, plans, frequencies and test methods).
  • Ensuring adherence to all organisational and external regulatory requirements.

Requirements:

  • Degree or masters degree in engineering, or related disciplines
  • 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 - capable of operating and liaison at all levels including managerial, project and technical.
  • Broad knowledge of materials and processes applicable to medical device industry is desirable.
  • 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 preferred
  • Working knowledge of FDA, GMP, QSR and ISO 13485 requirements.
  • Experience of preparing technical documentation
  • Excellent communication, organisational and time management skills
  • Flexibility to travel to vendor sites to support service and project activities.

Availability to travel may be required