Senior Compliance Engineer – Digital Health
Core
Lead product compliance strategy and drive compliance activities throughout the product lifecycle for Stryker's Smart Care portfolio of Software as/in a Medical Device (SaMD + SiMD) solutions.
Role type
Senior individual contributor compliance engineer
Builds
Digital health solutions supporting caregivers, patients, and families
Domain
Medical devices / Digital health / Regulatory compliance
Required skills
Compliance engineering, Regulatory strategy, Risk assessment, Test strategy definition, Third-party lab management, Cross-functional collaboration
Preferred skills
Medical device product development lifecycle, Safety regulatory certification (IEC 60601, FCC, IEC 62368), Wireless 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 cross-functional teams to integrate compliance into system architecture; Define compliance test strategies and manage external testing laboratories; Serve as a technical compliance subject matter expert during design reviews and risk assessments.
Seniority
Senior, hands-on IC