Systems Engineer
$150,000–$200,000 year
On-sitePlymouth, Minnesota, United States
Plymouth, Minnesota, United StatesOn-siteContract$150,000–$200,000 yearBachelors DegreeEnterprise
ContractBachelors DegreeEnterprise
Job Summary
Support Acute Therapies products through the full lifecycle from feasibility to post-market surveillance by managing product requirements, traceability, and design history files. Drive solutions for system integration, verification, and validation of medical devices while anticipating technical risks and executing mitigation strategies. Resolve systems-related issues using analytical tools and influence cross-functional stakeholders to ensure adherence to FDA, ISO, and IEC design control procedures.
Required Qualifications
- 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.
- 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.
- Must be available for Plymouth, MN (Onsite) location.
- Must work 1st Shift.
- Must work M-F (40 hours).
- Must be able to lift 50 lbs.
Desired Qualifications
- Prior experience in medical devices, preferably for intensive care unit (ICU) or kidney care domains.
- Prior experience with internet-connected, software-enabled devices and/or cyber security.
- 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.
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