- Ensure the logical and systematic translation of user and project needs into a comprehensive set of system and sub-system requirements in collaboration with the technical design leaders.
- Take technical ownership of the product throughout its lifecycle and provide effective technical leadership to the product and engineering teams.
- Resolve technical challenges by providing technical guidance to the product and engineering team through rigorous trade-off analysis to create robust and effective solutions.
- Facilitate cross-functional technical decision-making and optimize the balance between technical and schedule risk with the cost targets of the product lifecycle needs.
- Lead the integration of systems and devices, ensuring that the product meets the user and system requirements.
- Demonstrate the traceability of requirements through Validation and Verification.
- Lead the risk, hazard, and timeline analysis in to quantitatively evaluate design concepts & solutions
- Plan, coordinate, and manage system and cross-system design activities and interface directly with the product leadership team on project issues and status.
- Integrate sound design principles and standards into your programs including Design for Reliability, Manufacturing, and Service.
- Identify user groups, environments, use scenarios and critical tasks for task analysis, instructions, guides, user training and system verification
- Engage with the test teams to ensure plans for verifications and validation activities are successful
- Mentor other members of the organization on hospital connectivity and interoperability
- Initiate and lead activities such as Failure Modes and Effects Analysis (FMEA) that identify design issues and lead the team in developing mitigations to address these issues.
- Help the team members in developing high-quality documentation for all phases of product development, including design specifications, verification test plans, project schedules, and change orders associated with medical devices.
- Partner with the functional technical leaders (Architects/Principals) to develop significant and impactful Intellectual Property to fuel the growth of the business.
- Perform work in adherence to the Bracco Medical Technologies (BMT) Quality Management System (QMS), including development and maintenance of documentation
- Develops products that meet requirements regulated by FDA, EU regulatory body, PMDA and other governing bodies as defined by product management.
- Commit to fostering and driving an environment and work output based on continuous improvement
Principal Systems Engineer - Eden Prairie, United States - ACIST Medical Systems
Description
The Principal System Engineer position is a key technical leadership role at BMT and will integrate inputs and outputs to support the definition and development of complex software systems involving software services and multiple electro-mechanical medical device products. As design owner of a product solution, you are responsible for ensuring that your solution is built in accordance with customer, business, and regulatory requirements. This is done by effectively translating product requirements to design outputs, managing technical risks of the product, and following the technology roadmap. This position typically overlaps many technical and human-centered disciplines, including industrial engineering, functional engineering, human factors, marketing, regulatory affairs, quality assurance, and project management; a strong candidate will demonstrate a keen ability to facilitate cross-functional collaboration. The engineer is a key leader in development and management of support activities such as technical planning, systems integration, verification and validation, cost and risk, life-cycle management, and effectiveness for total systems.
Primary Duties & Responsibilities: