Senior Medical Devices Systems Engineer - Remote

Battelle; Kentucky; Hybrid; USD 129,000 - 184,000; Full time

Benefits offered by this job

Hybrid arrangement (60% in-office, 40%

Tuition assistance

401(k) with company match

Medical/dental/vision coverage

Job summary

Battelle is seeking a Sr. Systems Engineer for medical device development, based in Columbus, OH with remote options. You will guide interdisciplinary teams to meet client needs within tech, regulatory, and industry constraints.

The role focuses on system architecture, risk and requirements management, and regulatory compliance, with opportunities to influence product safety and performance in a collaborative environment.

Qualifications

• Bachelor’s or higher with required years of experience as specified; field relevant to product development.
• Proven track record leading cross-functional technical teams and managing risk.
• Experience with data analysis, statistics, DoE, and process mapping.
• Familiarity with medical device safety standards (IEC 60601, ISO 11608, ISO 10993, IEC 62368-1).
• Specialized expertise in domains like project management, microfluidics, optics, embedded systems, or related areas.

Responsibilities

• Technical planning: manage requirements, risk and integration plans; assist with schedules and resources.
• Technical execution: oversee tasks across mech, elec, software, usability, cybersecurity; ensure process conformance.
• System architecture: develop system and subsystem architectures with engineers; create block/context diagrams.
• Requirements management: develop and maintain system-level requirements with traceability.
• Risk management: create hazards analyses, FMEA, fault trees, safety and cybersecurity risk assessments.
• Build management: plan and coordinate limited prototype builds.
• Regulatory & standards compliance: support ISO 13485 and FDA regulations awareness.
• Client interaction: present reports to clients, manage meetings, and build relationships.
• Continual improvement: support process and capability improvements.

Skills

Cross-functional leadership

Data analysis

Design of experiments

Communication skills

Project management

Education

Bachelor’s degree in relevant field

Master’s degree in related field

PhD with 2 years of experience

Job description

Battelle is seeking a Sr. Systems Engineer for medical device development, based in Columbus, OH with remote options. You will guide interdisciplinary teams to meet client needs within tech, regulatory, and industry constraints.

The role focuses on system architecture, risk and requirements management, and regulatory compliance, with opportunities to influence product safety and performance in a collaborative environment.