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

Overview Position: Staff Process Engineer/ Medical Device Development [CAD, DFH, CAPA must require - Remote] Location: San Diego, CA (Remote work may be considered on a case-by-case basis) Duration: 12 Months Total Hours per Week: 40 Shift: 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) Responsibilities We are seeking a highly skilled, driven 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. Additionally, apply best practices from methodologies like DFSS (Design for Six Sigma) and Critical Parameter Management to project work and review/remediate software design control documentation. Minimum Qualifications Bachelor’s degree in Science or Engineering required; a postgraduate degree preferred Minimum of 5 years of related work experience in software engineering, medical device development, or similar fields; regulatory standards experience (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 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 team Ability to handle multiple tasks simultaneously and prioritize workload Technical Skills Strong background in software engineering and testing, 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 and Effects Analysis Extensive experience in the creation and maintenance of design and development documentation Knowledge of DFSS or statistical test design and analysis 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 Experience working in an agile development environment is a plus The candidate must be legally authorized to work in the United States without sponsorship now or in the future (e.g., H1-B) This is a hybrid position. Remote work may be considered on a case-by-case basis. #J-18808-Ljbffr MillenniumSoft Inc