- 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
- Bachelors' degree in Engineering, or other scientific discipline, preferably computer, software, or control engineering
- 10+ years of engineering experience
- 3-5 years new product development and exposure to systems engineering roles.
- 2+ years of working with development of software products
- Demonstrated experience with Enterprise Architecture and Systems Engineering
- Technical Risk Management & Mitigation for Cloud-hosted solutions in Medical Device "connected" domain
- Knowledge of network concepts and use, including firewalls, VLANs, routing, VPNs, etc.
- Experience with hospital system connectivity, including PACS, HIS/RIS, EMR
- Experience interfacing with Hospital IT customers, Radiologists, and imaging technicians
- Experience with network authentication solutions
- Demonstrated experience with risk management and systems engineering processes
- Demonstrated ability to clearly and accurately translate needs and requirements
- Ability to grow productive, trusting, and open relationships with a wide variety of constituencies.
- Excellent communication, influencing skills and ability to gain buy-in for initiatives
- High degree of organizational skills and high attention to detail
- Ability to handle multiple tasks and prioritize effectively
- Ability to work both independently and as part of a team
- Ability to develop protocols, conduct system tests and write reports
- Strong initiative and passion about new technologies with high energy
- Graduate degree in Engineering (Software or Systems) or another scientific discipline.
- 5+ years of research and development experience
- Familiarity with Medical Device Interoperability
- Experience with IHE profiles relating to IT infrastructure and device communication
- Experience with Active Directory integration
- Understanding of IT system virtualization techniques
- Experience with Hybrid & Cloud Services, Cloud-hosted Data & Deployments
- Experience with hybrid cloud deployments
- Experience working with physicians and customers in a medical device product development role
- Experience with product concept development, customer interaction, systems engineering, verification of engineering requirements, and validation of customer needs/design requirements
- Experience with risk management and systems engineering processes
- Ability to translate needs and requirements clearly and accurately
- Awareness and working knowledge of system-level constraints in all disciplines, including mechanical, electrical, human factors and software
- Voice-of-customer experience and fluency with clinical radiology terminology.
- Adheres to all company policies, procedures and business ethics codes
- Ability to travel up to 10% of the time
-
Systems Engineer I
4 weeks ago
IWCO Chanhassen, United StatesAt IWCO, we spend our days in the relentless pursuit of better ideas, better creativity and better performance across all direct response marketing channels. It's about being impactful, disciplined and measurable, while enjoying the process, being a part of a supportive team and ...
-
Software (Systems) Engineer
1 week ago
Genesis10 Eden Prairie, United StatesGenesis10 is currently seeking a Software (Systems) Engineer with our client in the manufacturing industry in their Eden Prairie, MN location. Responsibilities: Requirements analysis and design of servo drive algorithms such as ethernet network communications, low level periphera ...
-
Systems Engineering Manager
1 week ago
Cambria Eden Prairie, United StatesJob Description: · The Systems Engineering Manager is responsible for the performance and development of the employees in the section. This includes defining and managing necessary skill competency models and gap closure plans. Our team works cross-functionally to ensure that se ...
-
Systems Engineer I
6 days ago
IWCO Direct Chanhassen, United StatesAt IWCO, we spend our days in the relentless pursuit of better ideas, better creativity and better performance across all direct response marketing channels. It's about being impactful, disciplined and measurable, while enjoying the process, being a part of a supportive team and ...
-
Systems Engineer I
3 weeks ago
IWCO Direct LLC Chanhassen, United StatesJob Description · Job DescriptionAt IWCO, we spend our days in the relentless pursuit of better ideas, better creativity and better performance across all direct response marketing channels. It's about being impactful, disciplined and measurable, while enjoying the process, being ...
-
Systems Engineer I
6 days ago
IWCO Chanhassen, United StatesAt IWCO, we spend our days in the relentless pursuit of better ideas, better creativity and better performance across all direct response marketing channels. Its about being impactful, disciplined and measurable, while enjoying the process, being a part of a supportive team and h ...
-
Sr Systems Design Engineer I
6 days ago
Starkey Hearing Technologies Eden Prairie, United StatesThe Senior Systems Design Engineer I is responsible for leading the design of new products and ensuring that they meet associated requirements for total hearing system including, but not limited to; hearing aids, accessories, manufacturing software, fitting software, mobile appli ...
-
Embedded Systems Engineer: Power Electronics
1 week ago
Rogers Freels & Associates Inc Eden Prairie, United StatesJob Description · Job DescriptionRFA Engineering ) develops embedded software for our world-class clients in the areas of precision agriculture and vehicle electrification using state-of-the-art tools and processes. Visibility to a broad variety of applications in a highly collab ...
-
SW and Control Systems Engineer
1 week ago
Visium Resources, Inc. Chanhassen, United StatesJob Description · Job Description11033 · Introduction · Visium Resources has been asked to identify qualified candidates for this Software and Control Systems Engineer position. This position is a contract opportunity which is expected to be on-site in Chanhassen, MN for a durati ...
-
SW and Control Systems Engineer
1 week ago
Visium Resources Chanhassen, United StatesDetails: · Introduction · Visium Resources has been asked to identify qualified candidates for this Software and Control Systems Engineer position. This position is a contract opportunity which is expected to be on-site in Chanhassen, MN for a duration of six months with potent ...
-
Principal Systems Engineer
1 month ago
ACIST Medical Systems Eden Prairie, United States Full timeJob 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 devic ...
-
Engineering Systems Coordinator
3 weeks ago
Wood LLP Eden Prairie, United StatesWood Engineering Systems Coordinator · Wood has an opportunity for an Engineering Systems Coordinator to join our team in Qatar on a long-term basis. This role requires extensive interface with multi-location project execution teams as well as Project Systems personnel across the ...
-
Sr. Systems Engineer
2 weeks ago
US Bank Eden Prairie, United StatesJob Description · At U.S. Bank, we're on a journey to do our best. Helping the customers and businesses we serve to make better and smarter financial decisions and enabling the communities we support to grow and succeed. We believe it takes all of us to bring our shared ambition ...
-
IT Systems Engineer
2 weeks ago
Carver County Chaska, United StatesWe are seeking a talented System Engineer with expertise in virtual desktop technologies, PC management systems, and unified communications administration experience to join our dynamic team. The ideal candidate will be responsible for designing, implementing, and maintaining our ...
-
Systems Engineer
1 week ago
Beckman Coulter Diagnostics Chaska, MN, United States Full timeAt first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backg ...
-
IT Systems Engineer
2 weeks ago
Carver County, MN Chaska, United StatesSalary: $ $48.20 Hourly · Location : Chaska Government Center, MN · Job Type: Full-Time · Remote Employment: Flexible/Hybrid · Job Number: 02677 · Division: Public Services · Department: IT-Infrastructure Services · Opening Date: 05/13/2024 · Closing Date: 6/3/2024 4:30 P ...
-
Software Design and Control Systems Engineer
6 days ago
Abacus Chanhassen, United StatesJob Description: · Job Title: Software Design and Control Systems Engineer - Identity and Biometric Solutions Keywords: Number of Positions: 1 Remaining Positions: 1 Duties: · CFIUS and MRPT CLearance required · Experience with automation and PLC software integration · Highly ...
-
Software Design and Control Systems Engineer
1 week ago
Abacus Chanhassen, United StatesJob Description: Job Title: Software Design and Control Systems Engineer - Identity and Biometric Solutions Keywords: Number of Positions: 1 Remaining Positions: 1 Duties: CFIUS and MRPT CLearance required Experience with automation and PLC software integration Highly analytical ...
-
Software Design and Control Systems Engineer
1 week ago
MW Partner Chanhassen, United StatesJob Description · Job DescriptionMW Partners is currently seeking a Software Design and Control Systems Engineer to work for our client who is a global leader in the aerospace, defense and security markets. · Responsibilities and duties: · Develop and design machine controls for ...
-
Staff Systems Engineer
4 weeks ago
Beckman Coulter Diagnostics Chaska, MN, United StatesWondering what's within Beckman Coulter Diagnostics? Take a closer look. · At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be suppor ...
Principal Systems Engineer - Eden Prairie, United States - ACIST Medical Systems
Description
Job DescriptionThe Principal Systems 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:
Minimum:
