|Medical device company in upstate New York has an immediate opening for a Systems Engineering Manager with X-ray and Medical Imaging engineering experience.
The Systems Engineering Manager will have broad experience in leading a team of highly skilled Systems Engineers on complex medical device designs from the conceptual phase through successful product launch. This involves leading the requirements development, systems level architecture design, and interface design definition by collaborating with cross-functional disciplines within the product development environment.
His/her team will establish high level product requirements and systems architectures, and will collaborate with department function peers and Project Managers to create integrated technical designs and project schedules, ensuring that mechanical, electrical, and software subsystems function reliably as one integrated system. Key accountabilities include maintaining the technical competencies of the system engineering team by providing mentoring, training, evaluation, and recruitment.
- Facilitate architectural and design decisions to ensure on-time delivery of quality products, within cost, schedule, and performance constraints
- Lead system engineering processes, in particular establishing design inputs and top down design using various system requirement methodologies
- Drive hardware and firmware development through the product lifecycle within a stage/phase gate PDP, utilizing risk management techniques and automated requirements traceability tools
- Ensure team translates market-driven requirements into technical specifications, and ultimately flows them down into lower level hardware and firmware requirement documents
- Allocate the necessary resources and skill sets to projects ensuring technical, cost, quality, and schedule requirements are met. Manage resources to meet multiple project needs and objectives.
- Function well in a team environment. Gain consensus, lead, influence, and ensure cross-discipline participation and feedback.
- Work with Project Managers to create and maintain integrated program schedules using advanced scheduling tools and processes such as MS Project, Gantt charts, and WBS
- Act as technical expert within the system engineering function, advising and coaching subordinates to resolve technical or operational problems
- Set annual and ongoing goals and objectives for group members. Write and conduct annual appraisals for group members, actively assessing team's needs and gaps.
- Create metrics on tracking design efforts, resources, and effectiveness towards improving product development cycles and quality. Lead functional process and tool improvement initiatives by being early adopter of ideas. Foster creativity and innovation in design solutions.
- BS or MS degree in Systems, Mechanical, Electrical, Biomedical, or Computer Science. Strong technical foundation in engineering design principles.
- Minimum 10 years experience as a Systems Engineer in a regulated industry (i.e. medical, aeronautics, nuclear) developing complex electromechanical systems controlled by embedded/application software
- Minimum 5 years functional management experience
- Experience with digital x-ray equipment technology and imaging science
- System architecture experience with hardware/software for either medical devices or electro-mechanical devices
- Experience leading a team in the development of system level product requirements, including high-level system and specific sub-system architectures
- Successful product lifecycle experience, from the conceptual stage through product launch and into post-launch support. Working knowledge of stage/phase-gate product development process.
- Able to effectively interface with all project disciplines including Research, Product Development, Service Manufacturing, Regulatory, Marketing, Quality
- Broad technical experience including electrical, mechanical, and software engineering
- Experience in the development of processes and procedures which integrate systems engineering and modern design methodologies and associated tools
- Systematic approach to problem solving and issue resolution combined with good understanding of the relevant technologies and their practical applications
- Ability to effectively interface with team members in remote locations. Willing to travel; domestic and international.
- Develop the skills and abilities of the system engineering function. Define best-in-class functional processes, standards, and tools. Conduct ongoing performance benchmarking.
- Strong analytical, problem solving and negotiation skills
- Self-starter and capable of working with minimal supervision. Ability to multi-task and provide expertise and leadership across multiple projects.
- Good oral and written communication skills, especially technical writing
- Familiarity with medical device standards, such as FDA QSRs, MDD, ISO, UL/CE, and other international medical device requirements and standards
- Solid understanding of software development standards and embedded software technology
- Six Sigma or DFSS experience
Organizational Relationship: The Systems Engineering Manager will lead a team of up to eight Systems Engineers
No visa candidates please.