1253 IT & Software Developer jobs in the US
Systems Engineer with DevOps experience
$74,000 - 114,000
Axelon Services Corporation
Wall Street 44, New Kensington
$74,000 - 114,000
Requirements
Must:
- Proficient in interpreting and decomposing medical device standards, including IEC 60601-1-11, ISO 80601-2-70, and ISO 80601-2-72.
- Experienced in leading detailed FMEA (Failure Mode and Effects Analysis), assessing both full and partial failures of requirements to drive risk mitigation into specific subsystem requirements.
- Capable of ensuring all control measures are accurately reflected in the Risk Management File and Design History File (DHF) for compliance and audit readiness during the NPD sprint.
- Knowledgeable in defining how system-level risks translate into specific requirements for software, electrical, and mechanical subsystems to ensure critical performance.
- Skilled in developing V&V protocols and test plans as necessary.
- Competent in creating trace matrices throughout the V-model.
- Experienced in conducting technical reviews to align cross-functional teams on project direction.
- Minimum Education Requirement: Bachelors or Masters degree in Electrical, Electronic, Mechanical Engineering, Computer Science Engineering, or a related field.
- Minimum Experience Requirement: At least 5 years with a Bachelors degree or 3 years with a Masters degree in System Architecture, System Design, Hardware Engineering, or a similar field.
- Certification as an Engineering Professional (CSEP).
- Extensive experience in New Product Development (NPD) with a comprehensive understanding of the full product life cycle.
- Expertise in developing electromechanical devices that integrate hardware and software components.
- In-depth knowledge of medical device standards including ISO 14971 and the 60601 series.
Responsibilities
- Perform comprehensive system analyses and performance evaluations using advanced modeling and simulation methods to uncover optimization opportunities and address risks, typically with minimal supervision.
- Gather insights from leading research and current industry trends to guide system design choices and spearhead ongoing improvement efforts within the systems engineering field.
- Act as a liaison among various functional teams, such as R&D, manufacturing, and regulatory affairs, promoting effective communication and alignment on systems engineering requirements and benchmarks.
- Conduct thorough reviews and evaluations of system documentation and design artifacts, ensuring strict adherence to established systems engineering principles and industry standards.
- Oversee the development and execution of comprehensive systems engineering strategies, guaranteeing they align with organizational objectives and industry norms.
- Provide mentorship and support to junior systems engineers, sharing expertise and fostering their professional development in systems engineering principles and methodologies.
- Evaluate system requirements and produce detailed design specifications, applying sophisticated systems engineering techniques to enhance system performance and reliability.
- Innovate and implement Client systems engineering methodologies and tools, focusing on improving efficiency, quality, and agility in the system development lifecycle.
- Serve as a senior technical authority and point of escalation for complex systems engineering issues, offering expert advice and problem-solving capabilities.
- Champion cross-functional initiatives to develop and deploy process enhancements within the systems engineering framework, utilizing lean principles to optimize workflows and maximize productivity.
Description
We are seeking a skilled Systems Engineer to join our team in New Kensington, PA. Our company is dedicated to advancing technology in the medical device industry, and we offer a collaborative environment where innovation thrives. By joining us, you will benefit from opportunities for professional development, competitive remuneration, and a chance to make a significant impact in our projects. We value transparency, teamwork, and excellence in all our endeavors.
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You can find System Engineer salaries in the United States here.
How many System Engineer jobs are in the United States?
Currently, there are 1253 System openings. Check also: Linux jobs, Windows jobs, Network jobs - all with salary brackets.
Is the US a good place for System Engineers?
The US is one of the best countries to work as a System Engineer. It has a vibrant startup community, growing tech hubs and, most important: lots of interesting jobs for people who work in tech.
Which companies are hiring for System Engineer jobs in the United States?
Jump, Sched LLC, DataAnnotation, AMS Networks LLC, Hi-Temp Insulation, NewCold, MTech Systems among others, are currently hiring for System roles in the United States.
The company with most openings is Axelon Services Corporation as they are hiring for 51 different System Engineer jobs in the United States. They are probably quite committed to find good System Engineers.
The company with most openings is Axelon Services Corporation as they are hiring for 51 different System Engineer jobs in the United States. They are probably quite committed to find good System Engineers.