Software Development Process Engineer / Specialist (Medical Device)

591x Varian Medical Systems, Inc.; United States; On-site; USD 109,920 - 151,140; Full time

Benefits offered by this job

Medical, dental, vision, life and disability insurance

Paid time off and sick leave

401(k) retirement plan

Paid parking and public transportation support

Job summary

Join 591x Varian Medical Systems, Inc. as a Process Development and Governance specialist focused on shaping software product development for medical devices. Collaborate with global teams to enhance efficiency and compliance while embracing digital transformation.

This role requires a Bachelor's degree, 3–10 years in regulated software development, and expertise in Agile or DevOps frameworks. The position offers competitive pay and comprehensive benefits like insurance and 401(k). Come make a difference in healthcare!

Qualifications

• 3–10 years of experience in regulated software development, preferably in the medical device industry.
• Experience with Software Development Lifecycle (SDLC), Agile, or DevOps environments.
• Understanding of software requirements, architecture, and testing concepts.

Responsibilities

• Author, update, and maintain procedures for software design and development processes.
• Partner with engineering and product teams throughout lifecycle phases.
• Identify inefficiencies and drive continuous improvement initiatives.

Skills

Process orientation

Technical literacy

Collaboration

Facilitation

Communication

Analytical thinking

Proactive mindset

Education

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

Job description

Join us in pioneering breakthroughs in healthcare. We are a global community that celebrates diversity and supports professional growth. At Varian, a Siemens Healthineers company, we are committed to creating a “World Without Fear of Cancer”. This role is part of the PTP – Processes Team.

Role Overview

As a Process Development and Governance specialist, you will shape how software products for medical devices are developed, documented, and continually improved across our global organization. You will partner with global product development teams to ensure processes are efficient, compliant, and aligned with regulatory standards while advancing modernization initiatives such as digitalization and AI-enabled process innovation.

Key Responsibilities

• Process Development & Governance
  • Author, update, and maintain procedures and work instructions supporting software design and development processes.
  • Ensure processes support controlled, planned, and documented software development across the full product lifecycle.
  • Align process documentation with key design control elements, software safety and cybersecurity considerations.
  • Support readiness for audits and regulatory inspections by ensuring documentation and processes are complete and traceable.
• Software Development Lifecycle (SDLC) Support
  • Partner with engineering and product teams to ensure processes support lifecycle phases: Concept and planning, Iterative development, Verification and validation, Release and design transfer.
  • Support process alignment with agile practices, including backlog management, user stories, Definition of Done, and release readiness.
  • Collaborate with global stakeholders including R&D, Quality Assurance, Regulatory Affairs, Product Management, and DevOps.
  • Facilitate working sessions to identify improvement opportunities.
  • Support alignment across distributed teams (North America, Europe, India, China).
• Process Improvement & Digitalization
  • Identify inefficiencies and drive continuous improvement initiatives in software development processes.
  • Contribute to transformation toward digital, artifact‑driven evidence management, Agile and DevOps‑aligned workflows, and AI‑enabled process tools and insights.

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Quality, or related field.
• 3–10 years of experience in regulated software development (medical device industry preferred).
• Experience with Software Development Lifecycle (SDLC), Agile, or DevOps environments.
• Understanding of software requirements, architecture, and testing concepts; design controls (requirements, V&V, traceability); medical device software standards (SaMD, Digital Health IT) and frameworks (IEC 62304).
• Experience authoring or contributing to procedures, work instructions, or technical documentation.
• Interest or experience in digital transformation, process automation, or AI tools.

Key Skills & Competencies

• Process orientation – ability to translate complex development practices into structured, scalable processes.
• Technical literacy – working knowledge of software development and system lifecycle concepts.
• Collaboration – strong ability to work across global, cross‑functional teams.
• Facilitation – ability to lead discussions, workshops, and process alignment sessions.
• Communication – strong writing skills with attention to clarity, compliance, and structure.
• Analytical thinking – evaluate workflows and identify improvement opportunities.
• Proactive mindset – driven to improve processes and enable organizational success.

Benefits

• Competitive base pay range: $109,920 – $151,140 (geography and experience based).
• Medical, dental, vision, life and disability insurance.
• Paid time off, paid sick leave, and safe time.
• 401(k) retirement plan.
• Paid parking and public transportation support.

Equal Employment Opportunity Statement

Siemens Healthineers is an Equal Opportunity and affirmative action employer encouraging diversity in the workplace. All qualified applicants will receive consideration without regard to race, color, creed, religion, national origin, citizenship, ancestry, sex, age, disability, marital status, pregnancy, genetic information, sexual orientation, gender expression, gender identity, or veteran status. EEO is the law and applicants are protected from discrimination under federal law.