Staff Engineer, Advanced Operations, Digital

In this role you drive the optimization of digital medical device project processes, ensuring compliant implementation and smooth deployment. You’ll translate requirements into actionable instructions, validation docs, and training content, while shaping operational models for new applications. You collaborate with R&D, end users, customers, and partners to resolve technical topics and advance project delivery. You’ll seek improvements to legacy methods and build digital capabilities within a cross-functional, safety-conscious environment. This position offers impact across development and manufacturing in a fast-paced, regulated setting.

• comprehensive benefits package
• diversity initiative participation

• Develop and optimize processes for digital medical device projects to ensure efficiency and compliance
• Translate process requirements into work instructions, validation documentation, training materials, and deployment content
• Define and support operational support models and assess process impacts for new application deployments
• Collaborate with R&D, end users, customers, and development partners to resolve technical topics and enable project delivery
• Identify opportunities to improve legacy processes, tools, and ways of working while building digital and technical capabilities
• Collaborate with colleagues and external partners to develop safe, efficient, and scalable processes for digital medical technologies

• Degree in Engineering, Medical Technology, Computer Science, Natural Sciences or a comparable field
• 4+ years of experience in a regulated manufacturing environment (medical devices, aerospace, or automotive)
• Knowledge of design transfer and development lifecycle processes for software projects
• Understanding of ISO 13485 and applicable regulatory requirements
• Strong analytical, organizational, and problem-solving skills
• Ability to work independently and communicate effectively across functions

• Lean process development and continuous improvement (preferred)
• Cross-functional collaboration
• Effective written and verbal communication
• Familiarity with PLM/Windchill, ValGenesis, JIRA, or Confluence
• Experience with Microsoft Power Apps, Power Automate, SharePoint or similar digital tools
• Exposure to process validation, impact assessments, technical documentation, or user training