Software Development Process Engineer / Specialist (Medical Device)

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

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.At Varian, a Siemens Healthineers company, we are committed to creating a “World Without Fear of Cancer”. As part of the PTP (Processes, Technology, and Performance) – Processes Team, this role will play a critical part in shaping how software products for medical devices are developed, documented, and continuously improved across a global organization.This position focuses on process development, governance, and continuous improvement for software design and development lifecycle activities. The role partners with global product development teams to ensure processes are efficient, compliant, and aligned with regulatory standards, while also advancing modernization initiatives such as digitalization and AI-enabled process innovation.Key ResponsibilitiesProcess Development & GovernanceAuthor, 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 (concept through support).Align process documentation with key design control elements, software safety and cybersecurity considerations.Support organizational readiness for audits and regulatory inspections by ensuring documentation and processes are complete and traceable.Software Development Lifecycle (SDLC) SupportPartner 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 (Iterative development cycles, Backlog management and user stories, Definition of Done (DoD) and release readiness).Collaborate with global stakeholders including R&D, Quality Assurance, Regulatory Affairs, Product Management, and DevOps.Facilitate working sessions to understand how teams execute development activities and identify improvement opportunities.Support alignment across distributed teams (North America, Europe, India, China).Process Improvement & DigitalizationIdentify inefficiencies and drive continuous improvement initiatives in software development processes.Contribute to transformation toward:Digital, artifact-driven evidence managementAgile and DevOps-aligned workflowsAI-enabled process tools and insightsRequired QualificationsBachelor’s degree in Engineering, Computer Science, Quality, or related field3–10 years of experience in:Medical device industry (preferred), or regulated software developmentSoftware development lifecycle (SDLC), Agile, or DevOps environmentsUnderstanding of:Software requirements, architecture, and testing conceptsDesign controls (e.g., requirements, V&V, traceability)Medical device software standards (SaMD, Digital Health IT) and frameworks (e.g., IEC 62304 concepts)Experience authoring or contributing to:Procedures, work instructions, or technical documentationInterest or experience in:Digital transformation, process automation, or AI toolsKey Skills & CompetenciesProcess orientation: Ability to translate complex development practices into structured, scalable processesTechnical literacy: Working knowledge of software development and system lifecycle conceptsCollaboration: Strong ability to work across global, cross-functional teamsFacilitation: Ability to lead discussions, workshops, and process alignment sessionsCommunication: Strong writing skills with attention to clarity, compliance, and structureAnalytical thinking: Evaluate workflows and identify opportunities for improvementProactive mindset: Driven to improve processes and enable organizational successWhy Join Us?This role offers a unique opportunity to:Influence how medical device software is developed at scalePartner with global engineering, quality, and cross-functional teamsContribute to digital transformation initiatives including AI-enabled processesBuild broad domain knowledge across product developmentGrow into multiple career paths (process leadership, quality, product development, or digital transformation)Who we are: We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.To find out more about Siemens Healthineers businesses, please visit our company page here.The base pay range for this position is:$109,920 - $151,140Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.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 for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.EEO is the Law: Applicants and employees are protected under Federal law from discrimination. To learn more, click here.Reasonable Accommodations: Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [e-mail]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.California Privacy Notice: California residents have the right to receive additional notices about their personal information. To learn more, click here.Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”Data Privacy: We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.Beware of Job Scams: Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers career site.To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.