Lead Systems Engineer

Lead Systems Engineer

The Lead Systems Engineer works to align technology solutions with our business objectives, customer needs, and patient needs. Responsibilities include providing and developing technical expertise in a variety of industry concepts, practices, and procedures; inventing and demonstrating viability of new concepts and technologies; and designing and overseeing implementation of technology solutions.

Primary Responsibilities:

• Manage external partner/contractor deliverables to ensure project and technology goals are met
• Act as a subject matter and industry expert in technology concepts, practices, and procedures
• Conceive and demonstrate viability of new concepts and technologies
• Define and lead the implementation of system architectures and designs that align with business objectives, customer needs, and patient needs
• Engage and collaborate with diverse cross-functional teams to gather requirements, evaluate technical concepts, and make technical decisions
• Drive and contribute to requirements, design, implementation, integration, and testing
• Lead technical investigations related to new product development and product sustaining activities
• Evaluate and implement best practice product development processes, work instructions, and tools per applicable standards, such as IEC 62304 and IEC 61010-1
• Document results in clear, concise technical reports that support the product design history file and technical file
• Serve as a primary liaison with external consultants and contractors

  Qualifications/Requirements/Skills: 

• Bachelor of Science or higher degree in Software, Electrical, Mechanical, Optical Engineering or equivalent
• Minimum 8 years of relevant product development experience
• Strong experience throughout the product development lifecycle
• Strong experience with developing and sustaining embedded devices
• Excellent leadership skills with a demonstrated ability to lead distributed technical teams
• Excellent problem-solving skills with a preference to be hands-on
• Excellent verbal and written communication skills
• Preferred experience and working knowledge of medical device development, including a thorough understanding of and familiarity with 21 CFR 820.30, MDD, and ISO 13485 guidelines and standards
• Results driven and highly motivated self-starter that can work independently with minimal supervision
• Flexible with the ability to manage simultaneous tasks and adapt to changing priorities

Some travel required (< 20%)