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Position Title
Engineering Manager
Reports to
Managing Director
Division / Department
Equipment
Location / Site
Aurolab, Madurai
JOB PURPOSE:
We are seeking a highly qualified and experienced Medical Device System Engineer Manager to lead our cross-functional engineering team in the research and development of Class II and III medical devices. The ideal candidate will possess a deep understanding of customer, patient, and therapy needs, as well as product roadmaps, to drive innovative solutions that meet the highest standards of quality and compliance.
Key Responsibilities:
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.
Position Requirements:
Educational Qualifications: Bachelor's /Master's in Electronics Engineering
Experience: 20+ Years’ experience
Competencies:
(Technical & Behavioural)
- experience in a managerial role overseeing the development of Class II and III medical devices.
- understanding of design controls and regulatory standards (FDA, ISO, IEC).
- in ISO 13485, IEC 62304, ISO 14971, and IEC 62366 standards.
- with Six Sigma methodology.
- leadership and communication skills.