Senior Medical Device Engineer

4 weeks ago


Saint Paul, Minnesota, United States Luminary Group LLC Full time

Luminary Group LLC is seeking a highly skilled and experienced Senior Medical Device Engineer to lead the development and implementation of innovative medical device solutions.

As a Senior Medical Device Engineer, you will provide technical leadership and expertise in the development and implementation of medical device solutions, ensuring adherence to quality standards and regulatory requirements.

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.


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