Systems Engineer - Medical Device (Electro-Mechanical)

Job Description

Required Combination of Education and Experience: Bachelor's degree in Electrical, Software, Mechanical, or Biomedical Engineering AND 3+ years of experience OR Master's degree in Electrical, Software, Mechanical, or Biomedical Engineering AND 3+ years of experience

Required Skills For The Systems Engineer

• Prior experience in medical devices, preferably for intensive care unit (ICU) or kidney care domains
• Sound knowledge of systems engineering and related areas such as electro-mechanical and software engineering
• A track record in electro-mechanical system development, preferably in medical devices or other regulated products such as aerospace, automobile, or military
• Prior experience with internet-connected, software-enabled devices and/or cyber security
• Working knowledge of system modeling language (SysML or UML) and requirement management tools
• Knowledge of DOORS, Teamcenter, TrackWise8, JIRA, and ALM
• Familiar with statistical methods/tools for design and verification, e.g. DOE, sample size
• Success in working with multi-functional, global teams
• Excellent interpersonal, communication, and influencing skills
• Ability to work independently
• Ability to manage simultaneously several projects and shift priority according to needs
• Demonstrated strong analytical and problem-solving skills
• Ability to solve problems, develop solutions, and make recommendations in collaboration with project leaders
• Creative Problem Solver – identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks
• Ability to deliver results according to the plan

Systems Engineer Overview

In the Systems Engineer role, you will be supporting the overall technical direction of 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. Tasks may include product requirements management, traceability, DHF structure & maintenance, product risk management, system integration, verification, and validation of medical devices.

Responsibilities

Perform 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

Understand clinical and user needs and apply them to product realization

Capture inputs for requirements from various sources such as user needs, regulatory standards, human factors, quality, manufacturing, service, etc

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

Craft design concepts and research methodologies that best meet current and future customer / business needs for a product or process domain area

Create and maintain design history file elements

Facilitate an improved understanding of the interrelationship between requirements, risk and reliability

Anticipate technical challenges and risk scenarios and prepare, lead, and execute mitigation strategies to ensure optimal 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

Propose recommended mitigations with rationale

Influence stakeholders and cross-functional team members within the project

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

Use various software tools and programs to complete the above responsibilities

Benefits

For information and details on employment benefits offered with this position, please visit here.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.