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Senior Systems Architect

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

Kansas (USA), United States

Offer summary

Qualifications:

BS in Computer Science, Electrical or related Engineering field, 5-10 years professional experience in electromechanical and embedded systems development, Advanced knowledge of regulatory standards like ISO 13485/14971, IEC 60601, Experience with project leadership and mentoring Systems Engineers, Strong verbal, written, and interpersonal communication skills.

Key responsabilities:

Lead cross-functional engineering team from requirements to commercialization
Serve as primary technical contact for clients and internal teams
Conduct high-level design and safety analysis of complex devices
Mentor junior Systems Engineers and guide project deliverables
Partner with regulatory affairs and ensure quality adherence

Vantage MedTech SME https://vantagemedtech.com/

201 - 500 Employees

See more Vantage MedTech offers

Job description

Job Title: Senior Systems Architect
Location: Lenexa, KS
Department: Technical Services
Reports to: Engineering Manager/Director

Vantage MedTech provides comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. We develop and manufacture new products for the treatment of heart failure, cancer, stroke, Gene Therapy, COPD, TBI, Atrial Fibrillation, Blood Clots, Brain Surgery, and many more! We are searching for top-tier talent to apply their gifts to making life better for hundreds of thousands of patients worldwide. If this is something you aspire to, we would like to talk with you!

The Senior Systems Architect leads a cross functional engineering team in all stages of product development from high-level requirements capture, architecture conceptualization, integration, regulatory compliance, risk management, to product commercialization. This includes a broader team of engineers involving systems, electrical, software, and mechanical to resolve multi-discipline challengers. This role serves as the primary technical contact for both the client and internal team members and is responsible for high level design, architecture, and safety analysis of complex electromechanical and embedded medical device systems. The Senior Systems Architect provides technical expertise, guidance, and mentorship to Systems Engineers and requires minimal technical oversight.

**This is not a remote opportunity. This position is based in Lenexa, KS.  Candidate must either be local or willing to re-locate to the Kansas City metro area.

Key Responsibilities:

Technical lead of cross functional engineering team 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 team 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.
Oversees, statuses, and guides work of others and collaborates with the Project Manager to define project deliverables, schedule, and proposals.
Contributes to new platform development activities and projects.

Education and Experience:

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.

Top Benefits/Perks:
As a team member at Vantage MedTech, you’ll enjoy:

Comprehensive benefits package, including health, vision, and dental insurance.

Generous Paid Time Off.

Company retirement plan with matching.

Vantage MedTech values a diverse team and is an Equal Opportunity Employer.  We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. All applicants must be authorized for full-time employment in the United States.  For more information, visit www.vantagemedtech.com 

No third-party candidates please.