The Systems Engineer will be responsible for the verification and validation activities of electro-mechanical medical device systems, ensuring a detailed and well-tested design. The systems engineer's responsibilities include defining, clarifying, and documenting requirements and performing verification and validation testing. We are looking for a creative thinker - someone who takes a logical approach to solving problems and the product development process.
You will be part of a cross-functional team that develops and manages requirements, generates system and component requirements, implements the solutions in hardware and software, performs experiments, analyzes data, and ensures robust verification and validation testing.
In particular you can expect to:
+ Develop and interpret product requirements.
+ Plan, schedule, conduct, and monitor testing activities including requirement verification test development, test execution, and associated verification documentation.
+ Develop protocols and write reports for integrated system verification and validation testing.
+ Develop and execute verification and validation activities.
+ Use statistical techniques to analyze, summarize, and communicate test results and data.
+ Support planning and execution of Human Factors studies to ensure design meets user needs and reduces use errors.
+ Perform system reliability testing per design specifications and facilitate transition of product designs to full production.
+ Conceptualize, develop, and execute on reliability engineering test methods (such as HALT/HASS) to characterize reliability of electromechanical and electronic systems.
+ Participate in periodic design reviews of projects.
+ Interpret customer requirements and create product requirements, specifications, test protocols, and test reports.
+ 10+ years relevant work experience.
+ Experience with medical product development or other highly regulated environments highly preferred (ISO requirements and GMP guidelines, FDA regulations, GDPs, International regulation, and medical device design control).
+ Experience with structured development and engineering processes (emphasis on test and reliability engineering) and methodologies.
+ Strong background in both hardware and software engineering.
+ Experience working with engineering and other professionals in a cross-functional organization.
+ Strong self-management, prioritizing and multi-tasking skills to work within tight deadlines.
+ Candidate is a team player by nature with the ability to work independently with a result-oriented "can-do" attitude.
+ Experience in requirements management and traceability.
+ Working knowledge of international standards applicable to medical devices, including ISO13485, ISO14971, and IEC60601 and its collateral standards.
+ Experience in Phase-Gate Product Development process.
+ Expertise in common risk management techniques (FMEA, FTA, ETA).
+ Experience conducting DOEs, including DFSS tool utility for design down-selection is a plus.
+ B.S in systems engineering, electrical engineering, biomedical engineering, mechanical Engineering, or equivalent.
Participates in the design of semi-complex systems that integrate hardware and software. Provides support in semi-complex material specification, schematic preparation and appropriate follow-up. Participates in recommending ideas related to productivity improvement, cost reduction and improvement in customer satisfaction.