SUMMARY:
Primarily responsible for developing electro-mechanical systems and system architecture and its associated documentation per established quality system procedures. You will work with multi-disciplinary teams to meet product and project requirements, collaborating with engineers from a variety of companies and industries.
DUTIES AND RESPONSIBILITIES:
•\tResponsible for creating and building internal requirement sets and assisting the customer in developing user requirements, when needed.
•\tSupport developing the risk management plan and report.
•\tAssist in creation, review, and documentation of risk analyses.
•\tMay assist development of a Hazard Analysis.
•\tAccountable for ensuring product verification and validation and ensuring traceability is met for all requirements.
•\tCoordinate and facilitate interdisciplinary technical discussions within project teams.
•\tResponsible for coordinating and documenting system level analysis including system modeling, algorithm development, simulations, and system architecture.
•\tServe as the primary technical contact for customers on projects.
•\t Accountable for the technical project scope and effort.
•\tParticipate in the efforts to identify and implement technology re-use.
•\tPerform and participate in technical design reviews during product realization.
•\tAssist in evaluating technical talent.
•\tIdentify technical training and tools for the systems engineering team.
QUALIFICATIONS:
•\tBachelor's degree in Computer Science or an Engineering discipline.
•\tMaster’s Degree in Engineering is a plus.
•\tFive or more years of experience, preferable in the medical device field, in the discipline of systems engineering.
•\tExperience with system designs compliant with IEC 60601, ISO 13485, ISO/EN 14971, and IEC 62304 standards.
•\tExperience with requirements management tools is a plus.
•\tExperience with modeling tools (Matlab, Simulink, etc.) is a plus.
•\tKnowledge of FDA 510(k), PMA, and De Novo pre-market submission processes is a plus.
•\tExperience developing Class II and III medical devices is a plus.
Pay and Benefits
The pay range for this position is $40.00 - $62.00/hr.
Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Maple Grove,MN.
Application Deadline
This position is anticipated to close on Sep 3, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.