Software Quality Engineer (NO C2C)

Our client, a US Fortune 250 company and a global Medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an Software Development Engineer

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NOTE: THIS IS 100% ONSITE ROLE & ONLY W2 CANDIDATES (NO C2C/1099)

*** Candidate must be authorized to work in USA without requiring sponsorship ***

Position: Software Development Engineer (Job ID: CFNJP00049611)

Location: San Diego CA 92130

Duration: 12 Months + Strong Possibility of Extension

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We are seeking a highly skilled, drive, and experienced Staff Process Engineer (Software) with expertise in defining and implementing software design and development processes and design control deliverables that adhere to regulatory standards within the medical device industry. This role requires a strong technical background in Software Engineering, leadership capabilities, and extensive experience in product design and development. Experience in Quality and/or Systems Engineering is also a plus.

The engineer will play a critical role in shaping the process for defining and documenting software-centric design control elements and deliverables, as well as the software development process itself, ensuring alignment with regulatory requirements such as FDA guidance, and meeting both user and business needs. They will also be remediating the design control documentation for accuracy, completeness, and clear upstream and downstream traceability from software-centric design control elements. The ideal candidate will lead continuous improvement efforts, collaborate across multi-disciplinary teams, and provide technical expertise to ensure successful project outcomes.

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), 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.

Minimum Qualifications

• Education: Bachelor s degree in Science or Engineering is required; a postgraduate degree is preferred
• Experience: Minimum of 5 years of related work experience in software engineering, medical device development, or similar fields; experience with regulatory standards (e.g., IEC 62304, FDA guidance, IEEE standards) in a regulated industry is highly preferred
• Demonstrated ability to lead multi-disciplinary engineering teams and serve as a technical leader within the organization
• 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
• 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

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If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you. We're driven, people driven.

Bhupesh Khurana

Senior Technical Recruiter

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Amerit Consulting is an extremely fast-growing staffing and consulting firm. Amerit Consulting was founded in 2002 to provide consulting, temporary staffing, direct hire, and payrolling services to Fortune 500 companies nationally; as well as small to mid-sized organizations on a local & regional level. Currently, Amerit has over 2,000 employees in 47 states. We develop and implement solutions that help our clients operate more efficiently, deliver greater customer satisfaction, and see a positive impact on their bottom line. We create value by bringing together the right people to achieve results. Our clients and employees say they choose to work with Amerit because of how we work with them - with service that exceeds their expectations and a personal commitment to their success. Our deep expertise in human capital management has fueled our expansion into direct hire placements, temporary staffing, contract placements, and additional staffing and consulting services that propel our clients businesses forward.

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