Senior Compliance Engineer – Digital Health
Core
Lead product compliance strategy and drive compliance activities throughout the product lifecycle for Stryker's Smart Care portfolio (Software as/in a Medical Device and supporting hardware/sensors).
Role type
Senior individual contributor compliance engineer (digital health/medical devices)
Builds
Digital health solutions (SaMD + SiMD) supporting caregivers, patients, and families
Domain
Medical devices / Digital health / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Compliance engineering, regulatory requirements translation, product lifecycle management, risk assessment, test strategy definition, third-party lab management, cross-functional collaboration
Preferred skills
Medical device product development lifecycle, design controls, risk management, device regulatory certification (safety/EMC/wireless), telecom/non-medical device standards, software development life cycles
Technologies
IEC 60601-1, IEC 60601-1-8, FCC Requirements, IEC 62368-1, UL, TÜV, CSA, Intertek
Responsibilities
Lead product compliance strategy for new product development and sustaining engineering; Translate global regulatory requirements into design inputs and verification plans; Drive compliance activities from concept through commercialization; Assess compliance risks and predicate product considerations; Partner with teams to integrate compliance into system architecture and roadmaps; Define compliance test strategies and manage external testing laboratories
Seniority
Senior, hands-on IC