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

Join to apply for the Medical Device Development (software) (CAD, DFH, CAPA must required)- Remote role at MillenniumSoft Inc .

This position is for a Staff Process Engineer/Medical Device Development (software) (CAD, DFH, CAPA must required) with responsibilities including defining and implementing software design and development processes, ensuring compliance with regulatory standards, and leading continuous improvement efforts.

Position Details

• Location: San Diego, CA (Hybrid/Remote consideration)
• Duration: 12 Months
• Hours/week: 40
• Experience Level: Senior
• Employment Type: Contract on W2 (US Citizens, GC Holders, GC EAD, OPT, EAD, CPT)

Key Responsibilities

• Develop and implement software processes compliant with standards (IEC 62304, FDA guidance, IEEE)
• Remediate and develop software design documentation with clear traceability
• Translate regulatory requirements into processes and lead cross-functional teams
• Facilitate collaboration across departments and communicate project status effectively
• Identify process improvements and serve as a process and documentation expert

Minimum Qualifications

• Bachelors in Science or Engineering (Postgraduate preferred)
• At least 5 years in software engineering or medical device development, familiarity with regulatory standards
• Leadership experience in multidisciplinary teams
• Strong organizational, critical thinking, and communication skills

Technical Skills

• Background in software engineering, requirements management, and testing
• Experience with software development lifecycle, documentation, and methodologies like DFSS
• Knowledge of quality engineering and design control management
• Experience with ALM/PLM tools and agile environment is a plus
• Legal authorization to work in the US without sponsorship

This role may consider remote work on a case-by-case basis.