5+ years in software engineering, systems engineering, or medical device development.
Familiarity with regulatory standards in a regulated environment (e.g. IEC 62304, FDA guidance).
Background in quality engineering or project management is advantageous.
Demonstrated ability to lead cross-functional engineering teams.
Bachelor's degree in a STEM field, advanced degree preferred.
Certifications in Scrum, Agile, or INCOSE are a plus.
Responsibilities
Evaluate and remediate software design control gaps.
Correct and document traceability errors and develop requirements.
Assess test cases and identify additional testing needs.
Maintain comprehensive documentation of changes and rationales.
Achieve proficiency in Polarion and assist with data management.
Implement software design documents in line with updated templates.
Collaborate with stakeholders to ensure project alignment and address concerns.
Identify and mitigate risks throughout the development process.
Effectively communicate project statuses and technical concepts.
Pinpoint opportunities for process enhancements in software engineering.
Benefits
Collaborative work environment with cross-functional teams.
Opportunity to work on cutting-edge medical device technology.
Engagement in continuous improvement initiatives across software engineering.
Professional development and training opportunities available.
Full Job Description
Roles & Responsibilities
Evaluate and remediate gaps in software design control inputs (e.g., system/software requirements) and outputs (e.g., test documentation, software code).
Correct traceability errors, document missing traceability, and develop or decompose requirements as needed.
Assess existing test cases and determine additional testing needs, conducting back testing if necessary.
Maintain thorough documentation of changes and rationales.
Gain proficiency in Polarion and assist with data migration and tool population.
Modify and implement software design documents using updated templates within the Quality Management System.
Collaborate with stakeholders to ensure alignment and address feasibility concerns.
Identify and mitigate risks early in the process.
Communicate project status, technical concepts, and design details effectively.
Identify opportunities for process improvements in software engineering.
Experience Required
Minimum of 5 years in software engineering, systems engineering, medical device development, or design control management.
Experience with regulatory standards (IEC 62304, FDA guidance, IEEE standards) in a regulated industry preferred.
Background in quality engineering or project management is a plus.
Proven ability to lead multi-disciplinary engineering teams.
Skills & Certifications
Experience in software engineering, requirements management, test documentation, and traceability.
Strong understanding of regulatory compliance and risk mitigation (FMEA).
Proficiency in documentation, particularly for requirements and specifications.
Familiarity with Microsoft Office Suite and digital tools like Teamcenter, Polarion, SAP, DOORS, and ADO.
Excellent communication, problem-solving, and leadership skills.
Eligibilities & qualifications
Bachelor's degree or higher in a STEM field (postgraduate degree preferred).
Certifications in Scrum, Agile, or INCOSE are a plus.
Must be legally authorized to work in the U.S. without sponsorship.
