System Engineer

• Perform the activities associated with the Systems Engineering of one or more products in different stages of the product lifecycle from new product development to post-market surveillance

• Understand clinical and user needs and apply them to product realization

• Capture inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service, etc.

• Use knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a Systems perspective

• Initiate, develop, and lead feasibility by crafting design concepts and research methodologies that best meet both current and future customer / business needs for a product or process domain area

• Build and maintain Design History File elements and ensure traceability to requirements

• Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability

• Anticipate technical challenges and risk scenarios and then prepare, lead, and execute mitigation strategies to ensure safe and effective results

• Resolve systems-related technical issues by applying problem-solving tools such as cause and effect diagrams, Pareto charts, etc.

• Propose and drive solutions to technical problems that are ambiguous and diverse in scope

• Perform impact assessments on the Requirements on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigations, then propose recommended mitigations with the rationale

• Influence partners and multi-functional team members within the project

• Drive consistency to FDA, ISO and IEC design control procedures, regulations and standards

• Use various software tools and programs (e.g. DOORS) to complete the above responsibilities

• Teach and mentor others in life cycle management methodologies

Qualifications, Education and/or Experience

• A Bachelor's degree in Electrical, Mechanical, Biomedical, Controls, Systems, Software or other related technical/engineering field

• 3+ years of industry work experience

• Must possess sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering

• A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware

• Demonstrated strong analytical and problem-solving skills

• Success in working with multi-functional, global teams

• Excellent interpersonal/communication/influencing skills