Process Engineer
Core
Lead process governance, compliance, and operational excellence initiatives within Digital Innovation Platforms to ensure scalable and compliant ways of working.
Role type
Senior Process Engineer (Process Governance & Compliance)
Builds
Scalable, compliant operational frameworks for engineering, operations, cybersecurity, and quality organizations
Domain
Health technology, digital health, medical device, regulated software, cloud platforms
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
process mapping, root cause analysis, change management, continuous improvement, audit support, compliance program management, ISMS activities, regulatory inspection support, cross-functional leadership, strategic program ownership, enterprise-wide improvement driving, subject matter expertise, mentorship
Preferred skills
Lean Six Sigma Green Belt or Black Belt, PMP, ISO Lead Auditor, SAFe Agilist, Agile
Technologies
ISO 9001, ISO 27001, ISO 27018, HIPAA, HiTrust, CAPA, ISMS, cloud-based platforms
Responsibilities
Lead cross-functional initiatives involving engineering, operations, cybersecurity, and quality stakeholders; support audits, compliance programs, and regulatory inspections; drive enterprise-wide process improvements; serve as a subject matter expert and mentor; independently lead larger and more complex initiatives; influence multiple organizations and senior stakeholders; own strategic process governance programs
Seniority
Senior, hands-on IC with strategic influence
