What are the responsibilities and job description for the Principal Systems Engineer position at Saige Partners?
Job Description
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Contact Shawn Recker at srecker@saigepartners.com or 319-804-9996 to learn more about this opportunity!
Position Description
The Principal Systems Engineer role is a key technical leadership position responsible for overseeing the design of a product throughout its entire lifecycle. In this role, the engineer brings together multi-disciplinary inputs and outputs to guide the development of complex software-controlled electro-mechanical medical devices. As the design owner, you must ensure that the product meets customer expectations, business needs, and regulatory standards. This involves translating stakeholder needs into product requirements and design outputs, managing technical risks, and following the company's technology plans.
The Principal Systems Engineering role touches many areas, including industrial engineering, functional engineering, human factors, cybersecurity, marketing, regulatory compliance, quality assurance, and project management. A successful candidate will be skilled at promoting teamwork across different departments. The engineer also plays a leading role in activities like technical planning, systems integration, verification and validation, managing risks and costs, and overseeing the product's lifecycle to ensure it performs effectively.
Primary Duties and Responsibilities :
Translate user and project needs into a clear set of system and sub-system requirements in collaboration with technical design leaders and defined system architecture.
Take full technical ownership of the product throughout its lifecycle and provide strong leadership to product and engineering teams.
Solve technical challenges by guiding the team through detailed trade-off analysis to develop effective, reliable solutions.
Facilitate cross-functional decision-making and balance technical risks, schedules, and cost targets to meet lifecycle needs.
Oversee the integration of sub-systems and ensure the product meets user and system requirements, with clear traceability through validation and verification.
Lead risk, hazard, and timeline analysis to evaluate design concepts and solutions quantitatively.
Plan, coordinate, and manage cross-functional design activities while reporting project issues and progress directly to the product leadership team.
Incorporate design principles such as Design for Reliability, Manufacturing, and Service into all development efforts.
Identify user groups, environments, scenarios, and critical tasks to support task analysis, instructions, training, and system validation.
Collaborate with test teams to ensure successful planning and execution of verification and validation activities.
Initiate and lead Failure Modes and Effects Analysis (FMEA) to identify design issues and guide the team in developing solutions.
Assist team members in creating high-quality documentation, including design specifications, test plans, schedules, and change orders.
Work with technical leaders (Architects / Principals) to develop impactful Intellectual Property that drives business growth.
Follow the BMT Quality Management System and maintain documentation accordingly.
Ensure products meet applicable regulatory requirements from bodies such as the FDA, EU, and PMDA.
Promote a culture of continuous improvement, driving both process and product development forward.
Qualifications (Knowledge, Skills & Abilities) :
Required
Bachelor's degree in Engineering or a related scientific field, preferably in Electrical or Mechanical Engineering
10 years of engineering experience
5 years of experience in new product development, with exposure to systems engineering roles
Proven experience with risk management and systems engineering processes
Ability to accurately translate needs and requirements into clear technical outcomes
Skilled at building productive, trustworthy, and collaborative relationships across different teams and stakeholders
Excellent interpersonal and communication skills
Strong organizational skills with great attention to detail
Ability to manage multiple tasks and set priorities effectively
Capable of working independently and within a team environment
Experience developing protocols, conducting system tests, and writing detailed reports
High level of initiative, enthusiasm for new technologies, and strong work ethic
- Preferred
Graduate degree in Engineering (Electrical, Mechanical, or Systems Engineering) or a related scientific field
5 years of experience in systems engineering
Experience collaborating with physicians and customers during medical device product development
Understanding of system-level constraints across multiple fields, including mechanical, electrical, software, and human factors
Experience gathering customer feedback and familiarity with clinical radiology terminology
Skilled in experimental design, data analysis, statistical methods, and presenting findings
Experience with radiology systems and procedures
Saige Partners, one of the fastest growing technology and talent companies in the Midwest, believes in people with a passion to help them succeed. We are in the business of helping professionals Build Careers, Not Jobs. Saige Partners believes employees are the most valuable asset to building a thriving and successful company culture. Contact us to learn more about the opportunity below or check out other opportunities at
Meet Your Recruiter
Shawn Recker
