We are seeking a highly experienced and innovative Technical Manager, Systems Engineering to lead the design, development, and integration of complex systems, with a focus on advanced medical imaging technologies. The ideal candidate will drive end-to-end system development, ensuring compliance with industry standards and alignment with business needs. This role requires technical expertise, strategic leadership, and the ability to collaborate across diverse teams to deliver scalable and efficient solutions.

• Systems Design and Architecture:

o Design and develop comprehensive, scalable system architectures, covering integrations, data flows, infrastructure, and hardware interfaces for advanced medical imaging systems.
o Translate business requirements into detailed technical system designs and requirements.
o Lead the creation of high-level and detailed system architectures for complex, multidisciplinary systems.

• Product Development Leadership:

o Lead cross-functional teams in the development of complex products from concept to launch, ensuring delivery within established timelines, budgets, and quality standards.
o Manage software development processes using Agile and Waterfall methodologies, balancing technical goals with project constraints.
o Oversee system integration of hardware, software, firmware, and data components to ensure seamless functionality.

• Regulatory Compliance and Documentation:

o Ensure systems and processes comply with industry standards, including FDA 21 CFR Part 820 and IEC 62304.
o Oversee the creation, review, and maintenance of technical documentation to meet regulatory and industry requirements.
o Support FDA 510(k) submissions, CAPA processes, and audit activities.

• Collaboration and Communication:

o Collaborate with internal stakeholders, including Business, Clinical, Marketing, R&D, and Regulatory teams, to align objectives and technical solutions.
o Present project updates, milestones, and technical designs to senior management and external partners.
o Facilitate design reviews, manage feedback loops, and resolve technical trade-offs to refine and optimize solutions.

• Technical Leadership and Risk Management:

o Drive system modeling, simulation, and prototyping efforts to validate designs and reduce technical risks.
o Define project requirements, allocate resources, and proactively identify and mitigate risks to ensure project success.

Education: Bachelor's or master's degree in systems engineering, computer science, electrical engineering, or a related field. Advanced degrees are preferred.
Experience:
o 7+ years of experience in systems architecture and development, with a focus on medical devices or similarly regulated industries.
o Proven track record of leading cross-functional teams and managing complex product development lifecycles.

Skills and Knowledge:
o Expertise in systems design and software development methodologies (Agile and Waterfall).
o Strong technical proficiency in hardware/software integration.
o Exceptional problem-solving, risk management, and decision-making abilities.
o Excellent communication and interpersonal skills, with experience presenting to senior leadership and external partners.

Experience:
o 10+ years of experience in systems architecture and development, with a focus on medical devices or similarly regulated industries.

Skills and Knowledge:
o Significant experience in regulatory compliance (FDA 21 CFR Part 820, IEC 62304).
o Strong technical proficiency in system modeling and system-level prototyping.