MillenniumSoft Inc · 5 months ago
Staff Process Engineer/ Quality Systems Engineer - Remote
United States
Full-time
Remote
Senior Level
5+ years expMillenniumSoft Inc is a company specializing in medical devices, seeking a highly skilled Staff Process Engineer/Quality Systems Engineer. The role involves defining and implementing software design and development processes that comply with regulatory standards, while leading continuous improvement efforts and collaborating with multi-disciplinary teams.
Staffing & Recruiting
No H1B
U.S. Citizen Only
Responsibilities
Software Process Definition: Develop and implement software processes that comply with industry standards and regulations (e.g., IEC 62304, FDA guidance, IEEE standards), with a focus on the complete software development lifecycle
Software Design Documentation Remediation: Develop or modify and implement software design documentation templates within the Quality Management System that comply with industry standards and regulations. Clearly demonstrate end-to-end traceability where software design control elements are included, and remediate gaps and errors as needed
Leadership: Translate business and regulatory requirements into comprehensive software development processes. Conduct back testing and work collaboratively to ensure alignment with additional stakeholders, development teams, and business objectives. Maintain frequent and clear communication with team members and leaders working in all areas of the project. Identify risks and issues early on and implement mitigations as necessary
Cross-Functional Collaboration: Facilitate effective knowledge sharing and collaboration across departments (e.g., Systems Engineering, Hardware Engineering, Test Engineering, Quality, and others) to resolve alignment or feasibility issues. Communicate relevant project information effectively (verbal and written) including project status, technical concepts and design details, and functional demonstrations to key internal and external stakeholders of varying technical abilities
Continuous Improvement: Identify and drive opportunities for process improvement within the Software Engineering function to enhance efficiency, quality, clarity, and compliance
Technical Expertise: Serve as a resource for addressing and resolving issues of process and documentation. Apply best practices from methodologies like DFSS (Design for Six Sigma) and Critical Parameter Management to all projects. Review and remediate software design control documentation
Qualification
Required
Bachelor's degree in Science or Engineering is required
Minimum of 5 years of related work experience in software engineering, medical device development, or similar fields
Demonstrated ability to lead multi-disciplinary engineering teams and serve as a technical leader within the organization
Positive attitude with an aptitude for critical thinking
Willingness to learn and adapt to new challenges
Strong organizational skills, ability to work independently and with a group
Ability to handle multiple tasks simultaneously and prioritize workload
Strong background in software engineering and test, and requirements management
Experience in software product development, including user needs assessment, software system analysis, architectural design, integration and testing, Reliability Engineering, Project Management, and Failure Modes Effects Analysis
Exceptional communication skills, both interdepartmental and cross-functional
Strong writing abilities and attention to detail are essential
The candidate must be legally authorized to work in the United States without limitations and require no sponsorship for visa status now or in the future
Preferred
A postgraduate degree is preferred
Experience with regulatory standards (e.g., IEC 62304, FDA guidance, IEEE standards) in a regulated industry is highly preferred
Extensive experience in the creation and maintenance of design and development documentation is preferred
Knowledge and experience with methodologies like DFSS or statistical test design and analysis is preferred
Experience in Quality engineering and design control management is a plus
Experience with ALM/PLM tools is a plus
Experience working in an agile development environment is a plus
Company
MillenniumSoft Inc
Hire us to hire for you Staffing is not a straightforward activity.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Sailaja Mashetty
Partner - Customer Sucess
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