Staff Process Engineer/ Quality Systems Engineer - Remote

Position

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.

Key Responsibilities

• 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.
• 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.
• 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.
• 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.
• Identify and drive opportunities for process improvement within the Software Engineering function to enhance efficiency, quality, clarity, and compliance.
• 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.

Communication Skills

• Exceptional communication skills, both interdepartmental and cross-functional.
• Strong writing abilities and attention to detail are essential.

Experience

• Experience working in an agile development environment is a plus.