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Senior Systems Engineer

Vantage MedTech

Role overview

Qualifications

  • Bachelor’s degree in mechanical, electrical, or related engineering field
  • 8-10 years of professional experience in electromechanical and embedded systems product development
  • Experience with medical device development under quality systems
  • Advanced knowledge of ISO 13485/14971 and FDA class II or III medical device regulatory requirements

Responsibilities

  • Lead systems engineering activities, including requirements development, system architecture, and product design for medical device projects
  • Collaborate with cross-functional teams throughout the product lifecycle
  • Analyze customer and product requirements to define system-level specifications
  • Develop and execute verification and validation strategies, including test plans and reports

About the company

Vantage MedTech logo

Vantage MedTech

Medical Devices & Equipment

Vantage MedTech provides comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. Partnering with the world’s most innovative MedTech start-ups and large medical device companies, we offer feasibility support, product development and prototyping, new product development, clinical and commercial manufacturing, and after-market services to support every phase of the product life cycle. Our clients can leverage our proprietary Advantage Platforms™, accelerating product development timelines. Our manufacturing approach is structured to serve the changing needs of our clients, supporting small-quantity clinical or First-in-Human builds and can scale to accommodate full launch quantities. Vantage MedTech has facilities in Moonachie, New Jersey and Lenexa, Kansas. Visit www.vantagemedtech.com for more information.

Company details

Company typeSME
IndustryMedical Devices & Equipment
Company size201 - 500

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Job description

Job Title: Senior Systems Engineer
Location: Olathe, KS
Department: Technical Services
Reports to: Engineering Manager

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! 

We are seeking an experienced Systems Engineer to join our team. The Systems Engineer leads a development team to document, analyze, mitigate risks, create, test, and help with the manufacturing of complex electromechanical and embedded medical device systems, including both software and hardware aspects with Embedded, Real-time, PC, Linux, and Windows applications. The Systems Engineer III collaborates with cross functional engineering team in all stages of new product development from requirements management and system architecture to product commercialization and Manufacturing. The Systems Engineer III often consults with clients to determine system specifications and write requirements. Provides technical expertise, guidance, and mentorship to Systems Engineers. Collaborates with PMs to develop proposals.


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

Key Responsibilities:
  • Lead systems engineering activities, including requirements development, system architecture, and product design for medical device projects.
  • Collaborate with cross-functional teams, including software, electrical, mechanical, manufacturing, process, and test engineers throughout the product lifecycle.
  • Analyze customer and product requirements to define system-level specifications and ensure alignment with business and technical objectives.
  • Develop and execute verification and validation strategies, including test plans, procedures, protocols, and reports.
  • Maintain requirements traceability and ensure compliance with design control, quality, and regulatory requirements.
  • Troubleshoot and resolve complex system, hardware, software, and product design issues to support successful project execution.
  • Participate in risk management activities, design reviews, and phase gate reviews to ensure product safety, performance, and compliance.
  • Support product development from concept through commercialization, including manufacturing transfer and production support activities.
  • Mentor and provide technical guidance to junior engineers while driving engineering best practices and process improvements.
  • Partner with project managers, clients, clinicians, and other stakeholders to deliver innovative solutions on schedule and within budget.
Education and Experience:
  • Bachelor’s degree in mechanical, electrical, or related engineering field
  • 8-10 years of professional experience in electromechanical and embedded systems product development
  • Experience with medical device development under quality systems
  • Experience with Source Code Management, Requirements Management, and Defect Tracking systems
  • Experience providing written reports, test protocols, and engineering documentation for the testing of medical devices
  • Experience with “white box” testing and automated testing
  • Experience with FDA class II or III medical device regulatory requirements, or experience in similar regulated product development environment
  • Advanced knowledge of ISO 13485/14971, 93/42/EEC, 90/385/EEC, EN45502, EN60601-1, EN61000.
  • Demonstrated project leadership skills
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. 

 

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