Senior Engineer -Systems _ Hybrid (3 days/week)
Essential Duties and Responsibilities:
- Performs the activities associated with the Systems engineering of one or more products in various stages of the product lifecycle from new product development to post market surveillance.
- Gathers inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service and so on. Performs impacts assessment 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 mitigation. Come-up with the recommended mitigation with the rationale.
- Expedite, manage, and coordinate interrelated systems activities across functions, within the constraints of human and financial resources and changing priorities.
- Participate in identifying and planning tasks, activities, and resourcing needs related to systems engineering.
- Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability.
- Working knowledge of FMEAs and standards applicable to Systems Engineering.
- Creates design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area.
- Understands clinical and user needs and is able to apply to product realization.Creates and maintains Design History File elements.
- Successfully influences stakeholders and cross-functional team members within the project.
- Leverages knowledge of technology, process, and/or therapy domains to drive solutions and product design realization from a systems perspective.
- Leading labeling related verification activities, ensuring the manuals and other labeling deliverables are staying in compliance.
- Must possess sound knowledge of systems engineering disciplines and related areas like Electro-mechanical systems.
- A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware.
Qualifications:
- Must possess sound knowledge of systems engineering disciplines and related areas like Electro-mechanical systems.
- A demonstrated track record in electromechanical system development, preferably medical devices or other highly regulated products such as military hardware.
- Education and/or Experience:
- An engineering graduate in Electrical, Mechanical, Biomedical or related engineering discipline with 6 to 9 years of experience. Prior experience in Medical/Acute device domain is a plus.
- Additional Duties and Responsibilities in case if the role is performing LSD Lead System Designer/ PDO Product Design Owner:
- Thorough understanding and drives application of phases of life cycle management.
- Ability to apply life cycle management principles across all phases of life cycle management.
- Initiates, develops and leads technical feasibility analysis for product or subsystems; translates customer/user needs to product needs.
- Proposes and drives solutions to complex technical problems that are ambiguous and diverse in scope.
- Drives adherence to FDA, ISO and IEC design control procedures, regulations and standards.
- Anticipates technical challenges and risk scenarios and prepares, leads, and executes mitigation strategies to ensure optimal results.
- Teaches and mentors others in life cycle management methodologies.
- Can perform as an independent reviewer in technical and design reviews.
- Gathers inputs for Requirements from various sources such as Standards, User needs, Regulatory, Quality, Human factors, Manufacturing, Service and so on. Performs impacts assessment 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 mitigation. Come-up with the recommended mitigation with the rationale.
- Facilitate an improved understanding of the interrelationship between Requirements, Risk and Reliability.
