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Electromechanical Systems Architect

1 month ago


Lenexa, Kansas, United States Vantage MedTech Full time
Senior Systems Architect

Vantage MedTech is a leader in comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. Our team develops and manufactures new products for various medical conditions, aiming to make life better for hundreds of thousands of patients worldwide.

Job Overview

We are seeking a top-tier Senior Systems Architect to lead our functional engineering team in all stages of product development. The successful candidate will be responsible for high-level design, architecture, and safety analysis of complex electromechanical and embedded medical device systems.

Key Responsibilities:
  • Technical lead of cross-functional engineering teams in all stages of new product development from requirements management and system architecture to product commercialization on projects of moderate complexity.
  • Apply systems analysis techniques and procedures to determine system hardware and software functional specifications and requirements.
  • Serve as the primary technical contact for both client and internal team members; highly engaged with client's technical experts, clinicians, and marketing.
  • Responsible for high-level design and architecture of complex electromechanical and embedded medical device systems.
  • Lead risk management teams in safety analysis and risk documentation.
  • Partner with regulatory affairs for regulatory considerations and concerns on assigned projects.
  • Drive adherence to and application of the Quality Management System.
  • Consider project schedule and budget in producing pragmatic technical solutions and direction.
  • Mentor/coach junior Systems Engineers.
  • Estimate efforts and resources required for systems engineering and documentation tasks and actively work towards improving accuracy of personal estimates in comparison to actualized work effort.
  • Oversee, status, and guide work of others and collaborate with the Project Manager to define project deliverables, schedule, and proposals.
Required Skills and Qualifications:
  • Advance knowledge of ISO 13485/14971, IEC 60601, and other regulatory standards.
  • Advance knowledge of System Engineering principles, product development lifecycle, and current technologies.
  • Advance knowledge of Vantage MedTech's Quality Management System.
  • Understanding of multiple engineering domains (software, mechanical, electrical, process, etc.).
  • Experience executing project leadership skills and mentoring Systems Engineers.
  • Strong ability to adjust and set priorities to meet deadlines.
  • Strong verbal, written, and interpersonal communication skills.
  • Proficient documentation skills and attention to detail required.
  • BS in Computer Science, Electrical, or related Engineering field.
  • 5-10 years of professional experience in electromechanical and embedded systems product development.
  • Experience with high-level design including system level architecture, design tradeoffs, and constraints.
  • Experience developing technical requirements and risk management.
  • Experience with FDA class II or III medical device regulatory requirements, or experience in a similar regulated product development environment.
Benefits:
  • Average annual salary: $120,000 - $150,000.
  • Comprehensive benefits package, including health, vision, and dental insurance.
  • Generous Paid Time Off.
  • Company retirement plan with matching.