- Lead technical success of engineering Team in all stages of new product development from requirements management and system architecture to product commercialization.
- Primary technical contact for both client and internal team members; Highly engaged with client's technical experts, clinicians, and marketing.
- Drive a sense of urgency, product excellence and innovation to ensure project success.
- Coordinate closely with a broader team of engineers including electrical, software, mechanical, and test to resolve multi-discipline issues and develop compelling medical devices.
- Manage and lead resolution of systems engineering issues including architecture, hardware, and software design tradeoffs.
- Apply engineering theory, methods, and techniques to overcome technical and process related challenges in product development.
- Collaborate with Project Managers to develop proposals, lead the development team and produce designs that fulfill client vision.
- BS degree in Software, Electrical, Mechanical or Biomedical Engineering.
- 3+ years' experience in Systems Engineering for electromechanical and embedded systems product development.
- Experience with customized embedded electronics and software (this is not an information technology role).
- Demonstrated understanding of Systems Engineering tools and principles as applied to electromechanical and embedded systems (hardware and software) products.
- Ability to exercise sound judgment and make risk-based decisions to advance product development in a timely manner.
- Experience with high-level design including system level architecture, design tradeoffs and constraints.
- Experience developing technical requirements and risk management.
- Demonstrated project leadership skills.
- Excellent communication, interpersonal and problem-solving skills.
- Experience with FDA class II or III medical device regulatory requirements, or experience in similar regulated product development environment is a plus.
- Heart Failure
- Cancer
- Stroke
- Gene Therapy
- COPD
- Traumatic Brain Injury
- Atrial Fibrillation
- Rhinitis
- Back and Neck Pain
- Blood Clots
- Brain Surgery
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Systems Architect Engineer - Lenexa, United States - Sterling Medical Devices
Description
From high-level product requirements to architecture conceptualization and detailed safety analyses, the Systems Engineer will collaborate with software, electrical, mechanical, quality and test engineers to bring our clients' medical devices from design concept to commercialization. Our Company's medical products improve quality of life for patients every day. Our innovative products are developed by experienced, multi-disciplinary teams and require a high level of hardware and software integration. We are adding a Systems Engineer to our 40+ engineering team to support the growth of our vast portfolio of medical devices. This role requires communication to ensure feedback between customers, internal and external engineering teams that are both local and remote team members.
Responsibilities:
We are a cutting-edge medical device design firm located in the Kansas City metropolitan area. We partner with OEM companies worldwide to design and manufacture life-saving medical devices to be sold into the healthcare marketplace. Our culture is innovative, supportive, and focused on delivering the best medical device design and manufacturing services to their clients world-wide.
Our project list continues to grow and evolve into new therapeutic areas every year. In 2024 we will be developing new products for the treatment of:
Our Company 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
Local candidates only at this time, please. We do not offer relocation assistance.
No third-party candidates please.
