Engineering Manager

Understanding of Customer, Patient & Therapy Needs:

• Analyse and comprehend customer, patient, and therapy requirements to guide the development of medical device models and systems.
• Collaborate with stakeholders to ensure alignment between product development and user needs.

Regulatory Compliance:

• Demonstrate a thorough understanding of and adherence to FDA, ISO, and IEC design control procedures, regulations, and standards.
• Ensure that appropriate design controls are followed throughout sustaining engineering efforts and new product development.

Regulatory Standards Knowledge:

• Possess expertise in ISO 13485, IEC 62304, ISO 14971, and IEC 62366 standards.
• Stay abreast of changes in regulatory standards and implement necessary adjustments to ensure ongoing compliance.

Six Sigma Methodology:

• Apply Six Sigma methodology to enhance the efficiency and effectiveness of engineering processes.
• Drive continuous improvement initiatives to optimize product development workflows.

Team Leadership:

• Manage a small cross-functional engineering team comprising mechanical, software, electro-optical, firmware, hardware, and verification and validation experts.
• Foster a collaborative and innovative team culture, ensuring alignment with organizational goals.

Research and Development:

• Oversee the entire research and development process for medical devices, from conceptualization to market launch.
• Provide strategic direction for technology and product development, ensuring alignment with business objectives.

Quality Assurance:

• Implement and maintain robust quality assurance processes to ensure the reliability and safety of medical devices.
• Lead and support the team in verification and validation activities to meet regulatory requirements.

Competency Building and Training:

• Develop and implement training programs to enhance the competency and skillset of the engineering team.
• Foster a culture of continuous learning and development within the organization.

Recruitment and Team Building:

• Participate in the recruitment process, including hiring, on boarding, and training of new team members.