Katalyst CRO · 13 hours ago
Systems Engineers
New Kensington, PA
Contract
Onsite
Senior Level
5+ years expKatalyst Healthcares & Life Sciences is a company focused on medical devices and engineering solutions. They are seeking a Systems Engineer to perform system analyses, coordinate engineering requirements, and lead the development of systems engineering strategies while mentoring junior engineers.
Enterprise SoftwareBig DataPharmaceuticalHuman ResourcesAnalyticsBiopharmaData ManagementQuality Assurance
Responsibilities
Perform system analyses and modeling to identify optimization opportunities and risks
Apply research and industry trends to improve system designs
Coordinate systems engineering requirements across R&D, manufacturing, and regulatory teams
Review system documentation to ensure compliance with engineering standards and regulations
Lead development and execution of systems engineering strategies
Mentor junior systems engineers on methods and best practices
Analyze system requirements and produce detailed design specifications
Introduce and test new systems engineering tools and methodologies
Serve as a technical authority for complex systems engineering issues
Lead cross-functional process improvement initiatives using lean methods
Write product and element requirements with rationale
Decompose medical device standards (IEC 60601-1-11, ISO 80601?2?70, ISO 80601?2?72)
Lead deep-dive FMEAs
Evaluate requirement failures and translate findings into subsystem requirements
Ensure control measures flow into the Risk Management File and DHF
Translate system-level risks into software, electrical, and mechanical requirements
Develop V&V protocols and test plans
Build trace matrices across the V-model
Lead technical reviews to align cross-functional teams
Qualification
Required
Bachelor's / Master's Degree in Electrical Engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering or equivalent
Minimum 5 years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as System Architecture, System Design, Hardware Engineering or equivalent
Engineering Professional (CSEP)
Significant experience in New Product Development (NPD) and can speak to experience through the full product life cycle
Expertise developing electromechanical devices with hardware and software elements
Deep understanding of medical device standards such as ISO 14971 and the 60601 series
Product Development Lifecycle Management
Simulation Software
CI/CD
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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