Systems Engineer

Systems Engineer

Requirements

• Experience with writing and executing system verification and validation protocols.
• Experience with writing system-level requirements and working with different functional groups to define sub-system requirements.
• Must be a highly motivated self-starter who is able to achieve results with minimal direction.
• Requires a high-energy individual who has excellent teamwork, partnering, and negotiation skills.
• Must be proactive, organized and creative in achieving goals.
• Must have strong conflict resolution skills.
• Bachelor’s degree in engineering or scientific field and 4+ years’ engineering/systems engineering is required -OR-master’s degree in engineering or scientific field & 3+ years engineering/systems engineering experience is required -OR-PhD degree in Engineering or Scientific field.

Responsibilities

• Works directly with marketing, field sales, and clinicians to define high level system requirements, product concepts, user interfaces, patient-contact parts and disposables, and interfaces to external systems and medical devices.
• Initiate and lead in the improvement, design and optimization of highly complex experiments and tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products.
• Streamline development activities and define technical product development milestones.
• Works with electrical, software, algorithm and mechanical engineering groups to develop implementation-level engineering requirements and guide implementation direction.
• Works cross-functionally with engineering, quality, and regulatory groups on product risk management, usability, human factors, and regulatory standards compliance.

Preferred Qualifications

• Strong preference for experience in the medical device industry with emphasis on instrumentation/Monitors (analog and digital electronics) or medical sensors.
• Previous experience with UI/UX software development in the medical device industry.
• Previous experience working with requirement management tools such as PTC, JAMA or DOORS.
• Experience using Python or MATLAB.
• Familiarity with medical device industry standards (i.e IEC, ISO)
• Comfortable in a dynamic working environment with a high amount of change
• Previous electrical, software, mechanical, biomedical, or systems engineering experience working on electro-mechanical devices.
• Good leadership skills and ability to influence change
• Ability to manage competing priorities in a fast-paced environment