Acist Medical Systems
Principal Systems Engineer
Acist Medical Systems, Eden Prairie, Minnesota, United States, 55344
The Principal Systems Engineer role at Bracco Medical Technologies 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.
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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.
#J-18808-Ljbffr