Job Title: System Engineer
Location(s): New Kensington, PA
(Hybrid: 3 days in office)
Job Responsibilities:- Conducts in-depth system analyses and performance assessments, leveraging advanced modeling and simulation techniques to identify optimization opportunities and mitigate risks, working under limited supervision.
- Synthesizes insights from cutting-edge research and industry trends to inform system design decisions and drive continuous improvement initiatives within the systems engineering domain.
- Acts as a bridge between various functional teams, including R&D, manufacturing, and regulatory affairs, facilitating effective communication and alignment on systems engineering requirements and standards.
- Reviews and assesses system documentation and design artifacts with rigorous attention to detail, verifying compliance with established systems engineering principles and industry regulations.
- Leads the formulation and execution of comprehensive systems engineering strategies, ensuring alignment with organizational objectives and industry standards.
- Mentors and guides junior systems engineers, imparting specialized knowledge and fostering their growth in systems engineering principles and methodologies.
- Analyzes system requirements and generates detailed design specifications, employing advanced systems engineering techniques to optimize system performance and reliability.
- Innovates and pilots Client systems engineering methodologies and tools, aiming to enhance efficiency, quality, and agility in system development processes.
- Serves as a senior technical authority and escalation point for intricate systems engineering challenges, providing expert guidance and problem-solving expertise.
- Leads cross-functional initiatives to develop and implement process enhancements within the systems engineering framework, leveraging lean methodologies to optimize workflows and maximize productivity.
- Write Product and Element Requirements along with their rationales for those requirements.
- Standards Decomposition: Interpret and decompose medical device standards such as IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-72.
- Lead deep-dive FMEA (Failure Mode and Effects Analysis). Evaluate full and partial failure of requirements and drive those findings into specific subsystem requirements to mitigate risks.
- Ensure all control measures feed directly into the Risk Management File and the Design History File (DHF), maintaining a submission-ready audit trail through the NPD sprint.
- Define how system-level risks drive specific requirements into software, electrical, and mechanical subsystems to ensure essential performance.
- Develop V&V protocols and test plans as needed.
- Develop trace matrices across and up and down the V-model.
- Develop technical reviews to align cross-functional teams on the direction.
Requirements:- Minimum required Education: Bachelor's / master's degree in electrical engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering or equivalent.
- Minimum required Experience: 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.
- Minimum required Certification: N/A
- Preferred Education: N/A
- Preferred Experience: N/A
- Preferred Certification: Certified Systems
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.
Preferred Skills:- Product Development Lifecycle Management.
- Research & Analysis.
- Quality Specifications.
- Regulatory Requirements.
- Requirements Analysis.
- Business Acumen.
- Continuous Improvement.
- Strategic Planning.
- Systems Architecture.
- Systems Engineering.
- Systems Design.
- Systems Integration.
- Risk Management.
- Simulation Software.
- CI/CD.
