Systems Engineer Medical Devices (Electromechanical / Acute Therapies)"

Description:
You will be responsible for supporting the overall technical direction and work for novel Acute Therapies products.
Based on your technical skills, you will drive various portions of the product development cycle at stages ranging from feasibility through lifecycle management.
You will review and approve design concepts/changes and provide general direction to technical staff, including ensuring that quality is built into the design during new product development and/or sustaining activities.
Proactively supervising the program and developing strategies to mitigate technical risks is expected as well as reporting on the progress to senior management during routine cadence meetings.

Essential Duties and Responsibilities
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 skillss