Software Engineer/ Medical Device Development- Product Development - Remote

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

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