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Job Description

A client of Insight Global is looking for Systems Engineers with a strong background in risk and requirement management to help support their Patient Controlled Analgesia product lines. These systems engineers will be responsible for refining and reforming requirements, using risk analysis activities, for the software systems supporting the client's infusion pump products they release.

What you'll be doing:

• Drive the implementation of best practices in software systems development and product lifecycles in collaboration with development team

• Technical leader providing team members guidance and feedback on technical work.

• Develop technical solutions to complex software system problems and deliver high-quality solutions on tight schedules

• Lead cross-functional team members (e.g. Commercial and Clinical) to translate user needs into system requirements.

• Lead decomposition of system requirements into software subsystem requirements.

• Lead risk analysis activities for software from the capture of inherent hazards through mitigation implementation.

• Work with verification engineers to define test strategies for the development of verification and validation plans using requirement tracing methods.

• Participate in software design reviews for components or features.

• Agile planning/execution skills including estimating, scheduling, and completing committed schedules.

• Drive collaboration with internal and external stakeholders and enable the team on better processes, practices and technical mentorship. Transforming software requirements into software test architecture.

• Interface with manufacturing, service, and customer training staff through the design transfer process.

• 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 [email protected] 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/.

Skills and Requirements

• Bachelor’s degree in an engineering discipline with 10 + years of experience.

• Experience on electro-mechanical devices preferred.

• Experience with development in an agile environment with experience creating and maintaining product backlogs.

• Excellent oral and written communication skills.

• Experience in a regulated industry preferred.

• Excellent documentation skills. - In depth understanding of IEC 62304 requirements

- Experience handling traceability and the V-model