Job Summary

As a Senior Technical Lead specializing in mdr,ISO 13485, and mdd, the primary responsibilities include overseeing the technical aspects of projects related to medical device regulations and standards compliance. The role involves ensuring adherence to ISO 13485 quality management systems and the Medical Device Directive (MDD).

Key Responsibilities

1. Lead technical teams in the implementation and maintenance of systems compliant with iso 13485 and mdd requirements.
2. Provide expertise on mdr regulations and guidelines to ensure product development and validation processes meet the necessary standards.
3. Collaborate with cross functional teams to align technical strategies with regulatory requirements.
4. Conduct audits and assessments to verify compliance with mdr, iso 13485, and mdd requirements.
5. Develop and implement strategies to address technical challenges and optimize processes in compliance with medical device regulations.

Skill Requirements

1. Proficiency in interpreting and applying mdr regulations, iso 13485 standards, and the medical device directive (mdd).
2. Strong technical leadership skills to guide teams in achieving compliance goals effectively.
3. Excellent communication skills to interact with stakeholders and convey technical requirements clearly.
4. Analytical thinking to assess complex technical issues and develop appropriate solutions.
5. Detail oriented approach to ensure accuracy and precision in compliance related tasks.

Other Requirements

• Represent the design team and design control process from requirements development and design planning to design transfer& experience with product lifecycle
• Lead development of requirements flow down, Architecture/System design and analysis, risk analysis, Cybersecurity analysis, integration and test, manufacturing, field and customer support including corrective and preventative actions to ensure customer satisfaction.
• Collaborate closely with cross-functional teams to ensure that regulatory/country specific requirements and outputs are defined.
• Work closely with cross functional teams across sites to manage technical program risks, integration risks and design tradeoffs.
• Work to ensure QMS compliance, DHF readiness & regulatory to ensure Ultrasound product is regulatory compliance and commercialization.
• Contribute towards product strategy, drive architecture decisions, and design solutions to resolve challenging customer problems.
• Experience with IEC60601 standards and Product safety regulatory standards
• Experience with ISO13485, FDA, MDR, etc
• Experience in managing defect resolution activities for design changes, including analysis and defect disposition
• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.

 

Required Qualification

• Bachelor's degree in Engineering preferably with mechanical background
• 8+ years relevant work experience.
• Preferably with System or HW background
• Experience working with supply chain, suppliers, and product management.
• Hands-on approach with regards to installations, upgrades and repairs
• Strong problem solving, analytical, trouble-shooting skills.