Medical Device Development (software) [CAD, DFH, CAPA must required]- Remote

Position : Staff Process Engineer/ Medical Device Development (software) [CAD, DFH, CAPA must required]- Remote Location : San Diego, CA Duration : 12 Months Total Hours/week : 40.00 1st Shift Client : Medical Devices Company Job Category : Professional Level of Experience : Senior Level Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Job Description

• 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 & Experience

• Bachelor’s degree in Science or Engineering is required; a postgraduate degree is preferred
• 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
• 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

Technical Skills

• 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
• Exceptional communication skills, both interdepartmental and cross-functional
• Strong writing abilities and attention to detail are essential
• Experience working in an agile development environment is a plus
• 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 (e.g. H1-B status)

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