Senior Systems Engineer

Select Source International; Plymouth (MN); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Select Source International in Plymouth, MN is seeking a Senior Systems Engineer to drive systems engineering across the product lifecycle, from feasibility to post-market. You will capture requirements from clinical needs, regulatory standards, and stakeholders, and guide design realization with a systems perspective.

The role requires 3+ years in medical devices or regulated fields, strong SysML/UML and requirements practice, and collaboration across global teams to deliver compliant, robust

Qualifications

• Bachelor's or Master's degree in engineering or science.
• 3+ years of relevant experience in medical devices or regulated industries.
• Experience with system modeling languages and requirements management tools.
• Familiar with DOORS, Teamcenter, TrackWise8, JIRA, and ALM.

Responsibilities

• Lead systems engineering across the product lifecycle.
• Translate clinical and user needs into product requirements.
• Manage requirements, traceability, and DHF maintenance.
• Drive risk management and design verification activities.
• Coordinate with cross-functional teams and stakeholders.
• Ensure compliance with FDA, ISO and IEC design controls.
• Use various software tools to support responsibilities.

Skills

SysML/UML

Requirements management

Medical devices

Cross-functional collaboration

Risk management

Software/hardware integration

Education

Bachelor's or Master's degree in engineering or science

Tools

DOORS

Teamcenter

TrackWise8

JIRA

ALM

Job description

Job Title: Senior Systems Engineer

Duration: 12 months contract with potential to hire

Location: Plymouth, MN 55441 Hybrid

Description

Summary

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.

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 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
• 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

What You'll Bring

• 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 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

Experience And/or Background

• Bachelor s or Master s degree in Electrical, Software, Mechanical, Biomedical, or a related engineering or science discipline
• Three or more years of relevant experience