Systems Engineer (Medical Devices) - 2 Openings (Hybrid)

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Title: Systems Engineer (Medical Devices) - 2 Openings (Hybrid)

Location: Onsite at Plymouth, MN

Duration: 12 Months

Schedule: Tuesday to Thursday onsite, other days remote.

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered

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 and 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 cybersecurity

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

Candidates with an embedded software background are preferred.

This role will support Acute Therapies, specifically the dialysis machines used in ICU settings.

The individual should have a strong understanding of machine design and system functionality.

Responsibilities include designing and sustaining both new and existing features for the machine and its software, as well as overall system design.

Candidates must have experience working in regulated industries.

A background in the medical field is highly pref