Senior Systems Engineer

The Senior Systems Engineer supports the overall technical direction of acute therapies medical products and drives key elements of the product development lifecycle, from early feasibility through post-market lifecycle management. This role focuses on systems engineering for electro-mechanical medical devices, including requirements management, risk management, design history file maintenance, system integration, and verification and validation activities. The position requires strong technical expertise, independent work, and clear communication to collaborate effectively with cross-functional teams and ensure safe, effective, and compliant products.

Responsibilities

• Perform systems engineering activities for one or more medical device products across the full product lifecycle, from new product development through post-market surveillance.
• Understand clinical and user needs and translate them into clear, testable system and product requirements.
• Capture and consolidate inputs for requirements from user needs, regulatory standards, human factors, quality, manufacturing, service, and other relevant sources.
• Apply knowledge of technology, processes, and therapy domains to drive product design and realization from a systems perspective.
• Develop and refine design concepts and research methodologies that address current and future customer and business needs within the product or process domain.
• Create, organize, and maintain Design History File (DHF) elements to ensure complete and compliant design documentation.
• Establish and support traceability between requirements, risk management, verification, and validation artifacts.
• Facilitate an improved understanding of the interrelationship between requirements, risk, and reliability across the product and its subsystems.
• Identify, anticipate, and assess technical challenges and risk scenarios, and prepare, lead, and execute mitigation strategies to achieve optimal outcomes.
• Lead and resolve systems-related technical issues by applying structured problem-solving tools such as cause-and-effect diagrams and Pareto charts.
• Propose and drive solutions to complex, ambiguous technical problems that span multiple disciplines or subsystems.
• Perform impact assessments on requirements for proposed design, material, or process changes, as well as for observations from field, service, or manufacturing.
• Recommend and justify mitigation actions for identified risks or impacts, ensuring alignment with safety, quality, and regulatory expectations.
• Influence and collaborate with stakeholders and cross-functional team members, including engineering, quality, regulatory, manufacturing, and service, to drive project objectives.
• Ensure adherence to FDA, ISO, and IEC design control procedures, regulations, and standards throughout the development and lifecycle management process.
• Plan and support system integration activities, ensuring that electro-mechanical and software components work together as intended.
• Contribute to verification and validation strategies and activities to confirm that products meet requirements and user needs.
• Use various software tools and programs to manage requirements, documentation, risk, and other systems engineering tasks.
• Work independently while communicating clearly and proactively with team members and stakeholders to report status, risks, and issues.

• 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 in systems engineering or a closely related engineering role.
• Proven ability to work independently while collaborating effectively within cross-functional teams.
• Strong communication skills, with the ability to clearly convey technical concepts to diverse stakeholders.
• Demonstrated problem-solving skills and experience using structured tools such as cause-and-effect diagrams and Pareto charts.
• Sound knowledge of systems engineering principles, including requirements management, risk management, system integration, and verification and validation.
• Experience working with electro-mechanical and software-based systems, particularly in a regulated environment.
• Ability to interpret and apply FDA, ISO, and IEC design control procedures, regulations, and standards to product development and lifecycle management.

• Prior experience in the medical device industry, preferably in intensive care unit (ICU) or kidney care domains.
• Experience with electro-mechanical medical devices and associated systems engineering challenges.
• Familiarity with design history file (DHF) structure, creation, and maintenance in a regulated environment.
• Experience capturing and managing requirements from multiple sources, including clinical, regulatory, human factors, quality, manufacturing, and service.
• Ability to develop design concepts and research approaches aligned with customer and business needs.
• Experience performing impact assessments for design, material, or process changes and proposing appropriate mitigations.
• Proficiency with software tools used for requirements management, documentation, risk management, and related systems engineering activities.

This role operates in a professional office and laboratory environment focused on the development and lifecycle management of electro-mechanical medical devices for acute therapies. Team members collaborate closely with cross-functional partners in engineering, quality, regulatory, manufacturing, and service. The position follows a hybrid-style schedule with core in-office days typically on Tuesday through Thursday, supporting regular face-to-face collaboration while allowing flexibility on other days as business needs permit. Work involves extensive use of computers, engineering software tools, and standard office and development equipment, along with occasional interaction with prototypes and test setups in controlled lab settings.

Job Type & Location

This is a Contract position based out of Plymouth, MN.

The pay range for this position is $45.00 - $52.00/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)

This is a hybrid position in Plymouth,MN.

This position is anticipated to close on May 4, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.