Senior Medical Imaging Systems Lead

Jobtailor; Bothell (WA); On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor seeks a senior R&D leader to guide medical imaging systems from concept to launch through the phase-gate development process. You will lead cross-functional teams of engineers, clinicians, and marketing to define and evaluate innovative product concepts while ensuring regulatory alignment.

You will manage Design History Files (DHF), milestones, and critical-path activities, report progress to Senior Management, and collaborate with Quality and Regulatory on submissions and audits.

Qualifications

• Undergraduate degree in engineering or science field.
• 7–9 years of R&D experience and leadership of cross-disciplinary teams.
• Experience in regulated medical imaging product development and commercialization.
• Familiarity with ISO 14971 risk management and IEC 60601-1 safety standards.
• Ability to translate clinical needs into engineering solutions.
• Strong communication and project-management skills.

Responsibilities

• Lead cross-functional project teams from concept to launch using phase-gate process.
• Ensure compliance with industry guidance, standards, and regulations.
• Collaborate with clinicians, end users, and marketing to define concepts.
• Support sustaining engineering for in-house or contract-manufactured products.
• Manage DHF and technical deliverables; monitor milestones.
• Communicate project status to Senior Management.
• Coordinate engineering change requests to control scope and defects.
• Work with Quality and Regulatory on regulatory activities including 510(k) submissions.
• Respond to audits (FDA and ISO) and participate in post-market investigations.

Skills

R&D Experience

Team Leadership

Regulatory Knowledge

Project Management

Risk Management

Communication

Education

Undergraduate degree in engineering or science

Tools

DHF

Job description

Jobtailor seeks a senior R&D leader to guide medical imaging systems from concept to launch through the phase-gate development process. You will lead cross-functional teams of engineers, clinicians, and marketing to define and evaluate innovative product concepts while ensuring regulatory alignment.

You will manage Design History Files (DHF), milestones, and critical-path activities, report progress to Senior Management, and collaborate with Quality and Regulatory on submissions and audits.