Our client an indigenous Irish company who have recently secured significant investment are currently seeking a Senior Mechanical Engineer. The Senior Mechanical Engineer will be responsible for leading the design and development of the mechanical design for medical devices in line with CE & FDA regulations. The Senior Mechanical Engineer shall provide technical input in a cross-functional project team across an entire product road map, from concept through to launch.
Role/Responsibilities:
Lead the new product development in mechanical design
Responsible for the design, development, test, release and reliability of the mechanical design.
Perform verification and validation tasks on prototype and engineering build units.
Perform risk assessment, failure analysis, implement controls or mitigations to reduce risk levels.
Prepare technical documentation in clear and concise terms in accordance with the QMS
Maintain current working knowledge of the key international standards, regulations and regulatory guidance direction.
Communicate regular and accurate updates on project deliverables.
Provide guidance and support to junior staff members.
Perform other assigned tasks as directed by your manager.
Skills/Experience:
Honours Mechanical Engineering Degree or equivalent and similar work experience at a mid-level ideally working with but not exclusively within Medical Devices or/and Consumer Electronics
8 years + industry experience, preferably in medical or other highly regulated industry.
High standard of 3D Modelling skills (Solidworks)
Experience in taking a product design from initial concept with an industrial design partner through detailed design and transfer to manufacture
Knowledge of the IEC 60601 standard, ISO 13485 and ISO 14971 is an advantage
Previous packaging and/or Fabrics experience an advantage
Proficient in the use of MS Office applications such as Word, Excel, PowerPoint etc.
For further information please contact James Cassidy james.cassidy@lifescience.ie or call in confidence 086 0204322
