Principal Systems Engineer (Medical Devices)

Location: Plymouth, Minnesota, United States; minimum of 3 days per week onsite

Salary: $108,000–$148,000 annually, with potential discretionary bonuses

Company

hirify.global develops vital organ therapy products, digital solutions, and advanced services focused on improving dialysis and patient care.

What you will do

• Provide systems engineering direction for chronic therapy products throughout feasibility, new product development, lifecycle management, and post-market surveillance.
• Translate clinical and user needs into product requirements using inputs from regulatory, human factors, quality, manufacturing, service, and other stakeholders.
• Develop design concepts, support product realization, and create and maintain design history file elements.
• Manage the interrelationship between requirements, product risks, reliability, and proposed design, material, or process changes.
• Lead technical problem solving, impact assessments, risk mitigation, system integration, and verification and validation activities.
• Influence cross-functional teams, ensure adherence to FDA, ISO, and IEC design controls, and mentor colleagues in lifecycle management methodologies.

Requirements

• Bachelor’s degree with 5+ years of relevant experience, or master’s degree with 4+ years of relevant experience, in electrical, software, mechanical, biomedical, or related engineering or science disciplines.
• Strong knowledge of systems engineering and related electromechanical and software engineering principles.
• Experience developing electromechanical systems, preferably medical devices or other regulated products.
• Experience with internet-connected, software-enabled devices and/or cybersecurity.
• Familiarity with system modeling, requirements management tools, and root cause analysis methods.
• Strong analytical, problem-solving, communication, influencing, prioritization, and cross-functional collaboration skills.

Nice to have

• Prior experience in the medical device domain.
• Experience in aerospace, automotive, military, or other regulated product environments.
• Working knowledge of system modeling and requirements management tools.

Culture & Benefits

• Flexible workplace policy with regular in-person collaboration and a minimum of three onsite days per week.
• Medical, dental, and vision coverage beginning on the first day.
• 401(k) retirement savings plan, financial education, and investment resources.
• Paid time off, holidays, family and medical leave, and paid parental leave.
• Educational assistance, flexible spending accounts, childcare benefits, commuting benefits, and employee assistance programs.