Job Description
o Drive the implementation of best practices in software systems development and product lifecycles in collaboration with development and verification teams, for Digital Applications that are part of infusion pumps ecosystem
o Be a technical leader providing team members guidance and feedback on technical work.
o Develop technical solutions to complex software system problems and deliver high-quality solutions on tight schedules
o Lead efforts with cross-functional team members (e.g. Commercial and Clinical) to document user needs and translate them to user needs into system requirements.
o Lead decomposition of system requirements into software subsystem requirements.
o Lead risk analysis activities for Digital Applications software from the capture of inherent hazards through mitigation implementation.
o Work with verification engineers to define test strategies for the development of verification and validation plans using requirement tracing methods.
o Participate in software design reviews for components or features.
o Perform product backlog and feature grooming/definition activities as part of Agile planning/execution o Drive collaboration with internal and external stakeholders and enable the team on better processes, practices and technical mentorship.
o Interface with manufacturing, service, and customer training staff through the design transfer process.
o Ensure compliance to the product development process and quality system.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
- Subject matter expertise in requirements management and risk management for complex, medically regulated, connected/interoperable system of systems
- Experience writing risk files, assessing them, socialize and review them.
- Bachelor’s degree in an engineering discipline with 10 + years of experience
- Experience with Digital Applications (SaMD. MDDS) connected to regulated electro-mechanical devices in a clinical environment preferred.
- Experience with cloud service providers
- Experience with 14-9-7-1 (the international standard for medical standards
- Experience with development in an agile environment with experience creating and maintaining product backlogs
- Excellent oral and written communication skills and ability to speak with customers
- Experience in a regulated industry preferred
- Excellent documentation skills.
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.