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 Millennium Soft 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)

• 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

• 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.

• 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

• 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.

• Mid-Senior level

• Contract on W2

• Engineering and Information Technology

• Medical Devices