Global Medical Systems Engineer - Lead & Integration

RESOLVEM USA; Irvine (CA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

RESOLVEM USA is seeking a highly skilled System Engineer to design and update DHF/DMR records, lead technical teams, and drive new capital equipment introductions for medical devices. You will interface with distributed design teams and customers, manage project plans, tests, and documentation, and travel up to 25% globally.

The role requires a Bachelor’s in Mechanical or Electrical Engineering, 5+ years in engineering with medical devices, and 3+ years of cross-functional leadership in SW/HW.

Qualifications

• Bachelor's degree in mechanical or electrical engineering required.
• 5+ years in engineering with product development responsibility in medical devices.
• 3+ years of cross-functional technical leadership in system engineering (SW/HW).
• Experience with design control, ECOs, CAPAs, and software version control preferred.

Responsibilities

• Write system specifications, architecture, and design.
• Lead sub-system teams and document top-level design.
• Plan and conduct system integration and Proof of Design tests.
• Plan verifications and validations for systems and sub-systems.
• Develop simulations/models and lead feasibility studies.
• Interface between external vendors and customer teams.
• Conduct bench, V&V testing and produce reports.
• Ensure compliance with electrical standards for medical devices.
• Perform software evaluations and system analysis.
• Travel up to 25% to customer sites.

Skills

System engineering

Technical leadership

Software development

Medical devices knowledge

Education

Bachelor’s degree in Mechanical/Electrical Engineering

Job description

RESOLVEM USA is seeking a highly skilled System Engineer to design and update DHF/DMR records, lead technical teams, and drive new capital equipment introductions for medical devices. You will interface with distributed design teams and customers, manage project plans, tests, and documentation, and travel up to 25% globally.

The role requires a Bachelor’s in Mechanical or Electrical Engineering, 5+ years in engineering with medical devices, and 3+ years of cross-functional leadership in SW/HW.