You will convert business needs into system design and requirements, ensuring timely delivery and quality of Systems Engineering deliverables for these products while meeting customer needs, business objectives, and strategic goals.
Expected responsibilities include driving solutions on product development core teams to systems problems, owning the risk management deliverables for the projects you are assigned to, all the while ensuring user experience is translated into system design and requirements. The candidate should be versed in current product development methodologies (Agile, stage-gate) and act as a change agent in driving a more agile approach to systems engineering and application development.
- Plan, oversee, contribute to, and directly implement systems engineering requirements management within an overall product development effort.
- Plan, oversee, and directly drive the Risk Management and Mitigation deliverables
- Define critical interfaces between subsystems and leading subsystem team leads in the integration of sophisticated software driven electro-mechanical devices to ensure proper system function.
- Work with the Systems Engineering team to establish state-of-the-art technical capabilities. Provides input to technology strategy driving a future vision that forms our future products and enabling technologies.
- Help to develop systems and processes in line with FDA, IVDD & ISO9000 guidelines/directives while improving agility of processes in line with Mobile App and cloud-based system development best practices.
- Provide presentations, seminars, manuscripts and other information to support the technical integrity of the systems engineering function both internally and externally. Effectively communicate the activities of the systems engineering group to peers and more senior management.
- Bachelor’s Degree with 5 - 10 years in Engineering.
- Previous experience working in systems engineering in industry with background in Electrical Engineer, Computer Engineering, Computer Science, Mechanical Engineering, or Biomedical Engineering
- Systems thinker/thought leader able to lead cross-functional discussions
- Experience working in an Agile or hybrid agile/iterative development processes
- Experience working in global teams across time zones
- Experience working with engineering and other professionals in a cross-functional matrix organization
- Experience with medical devices and/or IVD devices a plus
- Experience with iOS and Android mobile app development or mobile UI design & architecture a plus
- Strong interpersonal skills to negotiate and reconcile competing differences.
- Excellent verbal and written communication skills.
- Successful team participation on complex engineering systems
- Strong evidence of excelling at strategic thinking that strikes the right balance of business, technology, and commercial objectives and goals
** This opening requires that candidates have either a Green Card or US Citizenship **