MillenniumSoft Inc
Software Engineer/ Medical Device Development- Product Development - Remote
MillenniumSoft Inc, San Diego, California, United States, 92189
Overview
Software Engineer/Medical Device Development - Product Development - Remote Join to apply for the
Software Engineer/Medical Device Development - Product Development - Remote
role at
MillenniumSoft Inc Location: San Diego, CA Duration: 12 Months Total Hours/Week: 40 Shifts: 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) Key Details
Location : San Diego, CA Duration : 12 Months Total Hours/Week : 40 Shift : 1st Shift Client : Medical Devices Company Job Category : Professional Level of Experience : Senior Level Employment Type : Contract on W2 Responsibilities
Define and implement software design and development processes and design control deliverables that adhere to regulatory standards within the medical device industry. Apply strong technical background in Software Engineering, provide leadership, and contribute to product design and development. Support Quality and/or Systems Engineering activities as needed. Lead the process for defining and documenting software-centric design control elements and the software development process, ensuring alignment with regulatory requirements (FDA guidance) and user/business needs. Remediate design control documentation for accuracy, completeness, and clear upstream/downstream traceability from software-centric design control elements. Lead continuous improvement efforts, collaborate across multi-disciplinary teams, and provide technical expertise to ensure successful project outcomes. Address and resolve process and documentation issues, applying best practices from methodologies like DFSS and Critical Parameter Management. Minimum Qualifications
Bachelor’s degree in Science or Engineering required; postgraduate degree preferred Minimum of 5 years of related experience in software engineering, medical device development, or similar fields; regulatory standards experience (IEC 62304, FDA guidance, IEEE) in a regulated industry highly preferred Demonstrated ability to lead multi-disciplinary engineering teams Positive attitude with critical thinking and willingness to learn Strong organizational skills; ability to work independently and in a team Ability to handle multiple tasks and prioritize workload Technical Skills
Strong background in software engineering, testing, and requirements management Experience in software product development: needs assessment, system analysis, architectural design, integration and testing, Reliability Engineering, Project Management, and FMEA Experience creating and maintaining design and development documentation Knowledge of DFSS or statistical test design and analysis is a plus Experience with Quality engineering and design control management is a plus Experience with ALM/PLM tools is a plus Excellent written and verbal communication; attention to detail Experience in an agile development environment is a plus Must be legally authorized to work in the United States without sponsorship now or in the future This is a hybrid position. Remote work may be considered on a case-by-case basis. Seniority level
Mid-Senior level Employment type
Contract on W2 Job function
Engineering and Information Technology Industries
Medical Devices
#J-18808-Ljbffr
Software Engineer/Medical Device Development - Product Development - Remote Join to apply for the
Software Engineer/Medical Device Development - Product Development - Remote
role at
MillenniumSoft Inc Location: San Diego, CA Duration: 12 Months Total Hours/Week: 40 Shifts: 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) Key Details
Location : San Diego, CA Duration : 12 Months Total Hours/Week : 40 Shift : 1st Shift Client : Medical Devices Company Job Category : Professional Level of Experience : Senior Level Employment Type : Contract on W2 Responsibilities
Define and implement software design and development processes and design control deliverables that adhere to regulatory standards within the medical device industry. Apply strong technical background in Software Engineering, provide leadership, and contribute to product design and development. Support Quality and/or Systems Engineering activities as needed. Lead the process for defining and documenting software-centric design control elements and the software development process, ensuring alignment with regulatory requirements (FDA guidance) and user/business needs. Remediate design control documentation for accuracy, completeness, and clear upstream/downstream traceability from software-centric design control elements. Lead continuous improvement efforts, collaborate across multi-disciplinary teams, and provide technical expertise to ensure successful project outcomes. Address and resolve process and documentation issues, applying best practices from methodologies like DFSS and Critical Parameter Management. Minimum Qualifications
Bachelor’s degree in Science or Engineering required; postgraduate degree preferred Minimum of 5 years of related experience in software engineering, medical device development, or similar fields; regulatory standards experience (IEC 62304, FDA guidance, IEEE) in a regulated industry highly preferred Demonstrated ability to lead multi-disciplinary engineering teams Positive attitude with critical thinking and willingness to learn Strong organizational skills; ability to work independently and in a team Ability to handle multiple tasks and prioritize workload Technical Skills
Strong background in software engineering, testing, and requirements management Experience in software product development: needs assessment, system analysis, architectural design, integration and testing, Reliability Engineering, Project Management, and FMEA Experience creating and maintaining design and development documentation Knowledge of DFSS or statistical test design and analysis is a plus Experience with Quality engineering and design control management is a plus Experience with ALM/PLM tools is a plus Excellent written and verbal communication; attention to detail Experience in an agile development environment is a plus Must be legally authorized to work in the United States without sponsorship now or in the future This is a hybrid position. Remote work may be considered on a case-by-case basis. Seniority level
Mid-Senior level Employment type
Contract on W2 Job function
Engineering and Information Technology Industries
Medical Devices
#J-18808-Ljbffr