Principal Engineer - Leading Medical Device Business - USA

Luminary Group is currently partnering with a leading medical device business in the USA and seeking a highly skilled and experienced Principal Engineer to join their team. As a Principal Engineer, you will provide technical leadership and expertise in the development and implementation of medical device solutions. This is a 6 to 12-month full-time employment opportunity.

Responsibilities:

• Lead the design, development, and implementation of innovative medical device solutions, ensuring adherence to quality standards and regulatory requirements.
• 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.

Requirements

• 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.