Senior Systems Engineer

Stefanini North America and APAC; Plymouth (MI); On-site; USD 69,000 - 73,000; Full time

Benefits offered by this job

PTO 10 days

Job summary

Stefanini North America and APAC is seeking a Systems Engineer (contract) to guide the technical direction of Acute Therapies products. You will drive design realization, requirements management, risk assessment, and system integration across the product lifecycle.

You will collaborate with global teams, ensuring adherence to FDA, ISO and IEC design controls, while leveraging SysML/UML, DOORS, Jama and other tools to maintain DHF elements and verification artifacts.

Qualifications

• Bachelor’s or Master’s degree in Electrical, Software, Mechanical, Biomedical or related engineering/science.
• Three+ years of relevant experience in medical devices or regulated products.
• Experience with system modeling and requirement management tools.

Responsibilities

• Perform systems engineering across product lifecycle from development to post-market surveillance.
• Understand user needs and regulatory requirements to guide design realization.
• Capture and manage inputs for requirements from diverse sources (regulatory, quality, manufacturing, service).
• Develop design concepts and drive risk management and verification activities.
• Maintain design history files and ensure traceability per FDA/ISO/IEC standards.
• Collaborate with cross-functional teams to mitigate technical risks and deliver results.

Skills

Systems engineering

Electro-mechanical

Software engineering

SysML/UML

Requirements management

Cross-functional teams

Education

Bachelor's/Master's in Engineering/Science

Tools

DOORS

Jama

Teamcenter

TrackWise8

JIRA

ALM

Job description

Location: Plymouth, MN 55441

Timing: 07:00 AM to 03:30 PM shift (Monday and Friday)

Pay rate: $50-53/- hourly on W2 with 10 PTO

Client is seeking a System Engineer (contract) to support 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 development of design concepts/changes, product requirements management, traceability, DHF structure & maintenance, product risk management, system integration, verification, and validation of medical devices.

What you'll be doing:

• 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 need 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, 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.
• Perform impact assessments on the requirements on an ongoing basis for any proposed design / material / process changes or observations from field / service / manufacturing. As needed, 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.

Required:

• Bachelor’s degree or Master’s degree and three years or more of relevant experience, with a degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline.
• 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 and Jama requirements management tools preferred.
• Knowledge of Teamcenter, TrackWise8, JIRA, and ALM preferred.
• 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.

Best regards,

Rachit Rastogi (Rick)