Principal TPM, SaMDVirtualVocations • Lincoln, Nebraska, United States
Principal TPM, SaMD
VirtualVocations • Lincoln, Nebraska, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]
A company is looking for a Principal TPM, SaMD (Remote).
Key Responsibilities
Lead planning and delivery of SaMD programs, ensuring compliance with software lifecycle processes and healthcare software safety standards
Collaborate with cross-functional teams to align on regulatory, quality, and engineering needs for medical device software solutions
Define and govern SDLC processes for SaMD development, integrating compliance controls and automation strategies
Required Qualifications
Bachelor's degree in Computer Science, Engineering, or a related technical field
10+ years of experience in technical program management, specifically in regulated environments
Experience with SaMD and knowledge of IEC 62304, IEC 82304, ISO 13485, and ISO 14971
Proven ability to translate regulatory requirements into technical workflows and automated compliance mechanisms
Strong leadership experience in driving cross-functional initiatives
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Principal • Lincoln, Nebraska, United States
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