Software SDLC Process Engineer

Siemens Healthineers AG; United States; Remote; USD 110,000 - 151,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick leave

Paid safe time

Job summary

Siemens Healthineers AG in the United States is seeking a Process Development & Governance professional to shape software design and development processes for medical device software across a global organization.

You will partner with engineering, quality, regulatory affairs, and DevOps to drive SDLC alignment with agile practices, design controls, and modernization initiatives including AI-enabled process tools.

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Quality, or related field.
• 3–10 years of experience in medical device or regulated software development.
• Understanding of software requirements, architecture, testing, and design controls (IEC 62304).

Responsibilities

• Author, update, and maintain procedures and work instructions for software design and development.
• Ensure processes support documented software development across the full product lifecycle.
• Support audits and regulatory inspections with traceable documentation.
• Collaborate with global R&D, QA, Regulatory Affairs, Product Management and DevOps.
• Lead process improvement sessions across distributed teams.

Skills

Process orientation

Technical literacy

Collaboration

Facilitation

Communication

Analytical thinking

Proactive mindset

Regulatory knowledge

Agile / DevOps

Education

Bachelor’s degree in Engineering, Computer Science, Quality, or related field

Tools

SDLC concepts

Agile / DevOps

Regulatory design controls

Job description

Siemens Healthineers AG in the United States is seeking a Process Development & Governance professional to shape software design and development processes for medical device software across a global organization.

You will partner with engineering, quality, regulatory affairs, and DevOps to drive SDLC alignment with agile practices, design controls, and modernization initiatives including AI-enabled process tools.