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Senior Medical Device Development Lead
2 months ago
Luminary Group LLC is seeking a highly skilled and experienced Principal Engineer to lead the development and implementation of medical device solutions.
Key Responsibilities:- Provide technical leadership and expertise in the development and implementation of medical device solutions.
- Collaborate with cross-functional teams to define technical requirements and translate them into product designs and architectures.
- Provide technical guidance and mentorship to the engineering team, promoting best practices and continuous improvement.
- Conduct feasibility studies, evaluate technical risks, and provide recommendations for mitigating potential issues.
- Drive innovation by staying up-to-date with emerging technologies and industry trends.
- Lead and participate in design reviews, ensuring robustness, scalability, and manufacturability of products.
- Oversee the development and execution of test plans, ensuring appropriate verification and validation of product designs.
- Collaborate with external partners and vendors to integrate and optimize components and subsystems.
- Ensure compliance with relevant regulatory requirements and standards for medical devices.
- Provide technical support and expertise to resolve issues and challenges during the product development lifecycle.
- Prepare and deliver technical presentations to stakeholders and customers.
- Mentor junior engineers and foster a culture of technical excellence and innovation.
- Bachelor's degree in engineering or a related field; advanced degree preferred.
- Minimum of 10 years of experience in the development of medical device solutions.
- Strong technical expertise in medical device design, development, and implementation.
- Proven track record of leading and delivering complex medical device projects.
- Deep knowledge of medical device industry standards, regulations, and best practices.
- Proficiency in relevant programming languages and software development methodologies.
- Experience with.Net, Azure DevOps, Docker, and Kubernetes.
- Experience with design control processes, risk management, and regulatory submissions.
- Excellent problem-solving and analytical skills, with the ability to find innovative solutions.
- Strong communication and leadership abilities, with the capability to collaborate effectively with cross-functional teams and stakeholders.
- Experience with product verification and validation, including test planning and execution.
- Ability to work in a fast-paced, dynamic environment and manage multiple priorities.
- Experience with Agile and/or Lean methodologies is a plus.
