Main responsibilities:Reliability Analysis & Testing: • Develop and execute comprehensive reliability test plans, and protocols, including accelerated life testing and failure mode analysis, to assess the durability and performance of graphene stimulation electrodes, thin films, integrated electronics, and related components.
• Oversee the qualification and validation processes for thin film technology and various encapsulation materials in neural interface devices.
Design and Process Improvement: • Collaborate with design, manufacturing, and quality teams to identify reliability challenges in device design and production.
• Support implementing design modifications and process enhancements to mitigate risk and improve overall product reliability and performance.
Data Analysis & Reporting: • Collect, analyze, and interpret reliability data to provide actionable insights for product development teams.
• Prepare detailed reports and presentations for internal and external stakeholders, including regulatory bodies, summarizing reliability performance and improvement strategies.
Regulatory & Quality Compliance: • Ensure all reliability testing and validation processes comply with applicable industry standards and regulatory requirements (e.g., FDA, ISO, IEC).
• Maintain detailed documentation to support audits and certifications.
Cross-functional Leadership: • Mentor and lead junior engineers and team members, fostering a collaborative environment that encourages continuous learning and innovation.
• Work closely with R&D, manufacturing, and external partners to drive reliability improvements and integrate cutting-edge materials and techniques into new product designs.
Innovation & Continuous Improvement: • Stay current with emerging industry trends, and technologies in medical devices, neural interfaces, thin film technology, stimulation equipment, and encapsulation materials.
• Champion best practices in reliability engineering and integrate new methodologies to enhance testing efficiency and product quality.
Mandatory Qualifications and Soft skills:- Master's degree in Electrical Engineering, Materials Science, Biomedical Engineering, or a related field.
- Minimum of 7 years of experience in reliability engineering, in the medical devices industry.
- Expertise in stimulation electrodes for neural interfaces, thin film technology, stimulation electronics, and various encapsulation materials.
- Strong analytical and problem-solving skills, with experience in failure analysis and reliability testing.
- Excellent communication and collaboration skills, with the ability to work effectively in a team environment.
- Able to work in lab and clean room environments
- Excellent problem-solving skills and attention to detail
- Strong communication and leadership abilities, with the capacity to mentor teams and work collaboratively across departments.
Nice to have:- PhD degree in the relevant technical topic, i.e. reliability of thin film technology, with stimulation electrodes, and its encapsulation technologies.
- Knowledge of regulatory requirements and standards for medical devices (e.g., ISO 13485, FDA regulations).
- Experienced in Python for test development and execution is a nice-to-have.
