Senior Systems Engineer

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

• Lead cross-functional project teams in designing and developing medical imaging systems from concept to launch through the phase-gate product development process
• Ensure products and processes comply with applicable industry guidance, standards, and regulations
• Work with clinicians, end users, and marketing to define and evaluate innovative product concepts addressing customer and business needs
• Support sustaining engineering initiatives for strategic products manufactured in-house or at contract manufacturing sites
• Support program management by managing technical product deliverables and Design History Files (DHF)
• Monitor project progress, manage critical-path activities, and ensure adherence to milestones and timelines
• Communicate project status through verbal and written reports to Senior Management
• Facilitate engineering change request quorum to manage project scope and defects
• Work with Quality and Regulatory Affairs on new-product regulatory activities, including country registrations and 510(k) submissions and follow-up
• Respond to internal and external audits, including FDA and ISO audits
• Participate in post-market investigations as needed

Requirements

• Undergraduate degree in an engineering or science discipline, including Biology, Biomedical Engineering, Chemistry, Chemical Engineering, Material Science, Mechanical Engineering, or another related discipline
• Minimum of 7–9 years of R&D experience
• Proven track record leading teams of Systems, BME, SW-E, ME, and/or EE engineers
• Experience developing and commercializing products within a regulated industry, preferably medical imaging
• Ability to understand clinical scenarios and conceptualize technical solutions
• Ability to explain concepts to implementation engineers
• Ability to test and evaluate designs and prototypes
• Knowledge of medical device risk management per ISO 14971 preferred
• Experience designing products and processes per industry standards
• Exposure to medical device safety standards such as IEC 60601-1 highly desired
• Ability to lift 25 lbs with or without accommodations
• Excellent written and verbal communication skills
• Strong interpersonal skills
• Strong analytical and organizational skills
• Ability to work in a fast-paced, small-team environment with minimal direction
• Ability to handle open-ended problems and ambiguity

Core Competencies

Demonstrates expertise in leading cross-functional teams to design and develop medical imaging systems while ensuring compliance with industry standards and regulations. Proficient in managing technical deliverables, project timelines, and facilitating communication among stakeholders.

Highest-signal resume keywords

• Medical Imaging System Development
• Regulatory Compliance
• Project Management
• Risk Management (ISO 14971)
• Team Leadership

ATS Optimization Keywords

Hard Skills

• R&D Experience
• Product Commercialization
• Design History Files (DHF)
• Clinical Scenario Analysis
• Prototyping and Testing
• Medical Device Safety Standards (IEC 60601-1)
• Engineering Change Management

Soft Skills

• Excellent Communication Skills
• Strong Interpersonal Skills
• Analytical Skills
• Organizational Skills
• Problem-Solving Skills

Industry Keywords

• Medical Device
• FDA Audits
• ISO Audits
• Phase-Gate Product Development
• Contract Manufacturing