MillenniumSoft Inc
Staff Process Engineer/ Quality Systems Engineer - Remote
MillenniumSoft Inc, San Diego, California, United States, 92154
Overview Staff Process Engineer / Quality Systems Engineer - Remote
Location: San Diego, CA
Duration: 12 Months • Total Hours/week: 40 • 1st Shift
Client: Medical Devices Company • Job Category: Professional • Level of Experience: Senior Level • Employment Type: Contract on W2 (US Citizens, GC Holders, GC EAD, OPT, EAD, or CPT eligible)
Note: This is a hybrid position. Remote work may be considered on a case-by-case basis.
Responsibilities
Define and implement software design and development processes and design control deliverables that adhere to regulatory standards within the medical device industry. Lead software process definition and remediation of design documentation to ensure end-to-end traceability and compliance with regulatory requirements (e.g., FDA guidance, IEC 62304, IEEE standards). Remediate design control documentation for accuracy, completeness, and clear upstream/downstream traceability from software-centric design control elements. Lead continuous improvement efforts, collaborate with multi-disciplinary teams, and provide technical expertise to ensure successful project outcomes. Translate business and regulatory requirements into comprehensive software development processes; communicate status and concepts to stakeholders at varying levels of technical ability. Facilitate cross-functional collaboration across Systems, Hardware, Test, Quality, and other departments to resolve alignment or feasibility issues. Apply best practices from methodologies such as DFSS and Critical Parameter Management to projects; review and remediate software design control documentation. Key Responsibilities
Software Process Definition: Develop and implement software processes that comply with industry standards and regulations (e.g., IEC 62304, FDA guidance, IEEE standards) across the full software development lifecycle. Software Design Documentation Remediation: Create or modify software design documentation templates within the Quality Management System; ensure end-to-end traceability and remediate gaps and errors as needed. Leadership: Transform regulatory requirements into comprehensive software development processes; maintain clear communication with team members and leaders; identify risks and implement mitigations. Cross-Functional Collaboration: Enable knowledge sharing across departments to resolve alignment or feasibility issues; communicate project status and design details to stakeholders. Continuous Improvement: Identify opportunities to improve software engineering processes for efficiency, quality, and compliance. Technical Expertise: Provide guidance on process and documentation; apply DFSS and related practices to projects; review and remediate software design control documentation. Minimum QualificationsEducation & Experience
Bachelor’s degree in Science or Engineering required; postgraduate degree preferred Minimum 5 years of related work experience in software engineering, medical device development, or similar; experience with regulatory standards (IEC 62304, FDA guidance, IEEE) in a regulated industry highly preferred Demonstrated ability to lead multi-disciplinary engineering teams and serve as a technical leader Positive attitude with critical thinking; willingness to learn and adapt Strong organizational skills; ability to work independently and in a team; ability to handle multiple tasks and prioritize Technical Skills
Strong background in software engineering, testing, and requirements management Experience in software product development: needs assessment, system analysis, architectural design, integration and testing, reliability engineering, project management, and FMEA Experience creating and maintaining design and development documentation; knowledge of DFSS or statistical test design is preferred Experience in Quality engineering and design control management is a plus Experience with ALM/PLM tools is a plus Excellent communication skills and attention to detail; ability to work in an agile environment is a plus Must be legally authorized to work in the United States without sponsorship now or in the future
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. #J-18808-Ljbffr Remote working/work at home options are available for this role.
Define and implement software design and development processes and design control deliverables that adhere to regulatory standards within the medical device industry. Lead software process definition and remediation of design documentation to ensure end-to-end traceability and compliance with regulatory requirements (e.g., FDA guidance, IEC 62304, IEEE standards). Remediate design control documentation for accuracy, completeness, and clear upstream/downstream traceability from software-centric design control elements. Lead continuous improvement efforts, collaborate with multi-disciplinary teams, and provide technical expertise to ensure successful project outcomes. Translate business and regulatory requirements into comprehensive software development processes; communicate status and concepts to stakeholders at varying levels of technical ability. Facilitate cross-functional collaboration across Systems, Hardware, Test, Quality, and other departments to resolve alignment or feasibility issues. Apply best practices from methodologies such as DFSS and Critical Parameter Management to projects; review and remediate software design control documentation. Key Responsibilities
Software Process Definition: Develop and implement software processes that comply with industry standards and regulations (e.g., IEC 62304, FDA guidance, IEEE standards) across the full software development lifecycle. Software Design Documentation Remediation: Create or modify software design documentation templates within the Quality Management System; ensure end-to-end traceability and remediate gaps and errors as needed. Leadership: Transform regulatory requirements into comprehensive software development processes; maintain clear communication with team members and leaders; identify risks and implement mitigations. Cross-Functional Collaboration: Enable knowledge sharing across departments to resolve alignment or feasibility issues; communicate project status and design details to stakeholders. Continuous Improvement: Identify opportunities to improve software engineering processes for efficiency, quality, and compliance. Technical Expertise: Provide guidance on process and documentation; apply DFSS and related practices to projects; review and remediate software design control documentation. Minimum QualificationsEducation & Experience
Bachelor’s degree in Science or Engineering required; postgraduate degree preferred Minimum 5 years of related work experience in software engineering, medical device development, or similar; experience with regulatory standards (IEC 62304, FDA guidance, IEEE) in a regulated industry highly preferred Demonstrated ability to lead multi-disciplinary engineering teams and serve as a technical leader Positive attitude with critical thinking; willingness to learn and adapt Strong organizational skills; ability to work independently and in a team; ability to handle multiple tasks and prioritize Technical Skills
Strong background in software engineering, testing, and requirements management Experience in software product development: needs assessment, system analysis, architectural design, integration and testing, reliability engineering, project management, and FMEA Experience creating and maintaining design and development documentation; knowledge of DFSS or statistical test design is preferred Experience in Quality engineering and design control management is a plus Experience with ALM/PLM tools is a plus Excellent communication skills and attention to detail; ability to work in an agile environment is a plus Must be legally authorized to work in the United States without sponsorship now or in the future
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. #J-18808-Ljbffr Remote working/work at home options are available for this role.