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Job Description
Senior Mechanical Engineer sought to lead design and development of medical devices in line with CE & FDA regulations, providing technical input in cross-functional project teams.
Key Responsibilities:
- Lead new product development in mechanical design
- Design, develop, test, release and reliability of 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
- Maintain current working knowledge of key international standards, regulations and regulatory guidance direction
- Communicate regular and accurate updates on project deliverables
- Provide guidance and support to junior staff members
Requirements:
- Honours Mechanical Engineering Degree or equivalent and similar work experience at a mid-level
- 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 through detailed design and transfer to manufacture
- Knowledge of 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