Technical Project Manager - SaMD (Software as a Medical Device) Job at Tekshapers Inc, Michigan

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  • Tekshapers Inc
  • Michigan

Job Description

Technical Project Manager - SaMD (Software as a Medical Device)

Location: 100% Remote

Duration: 6+ Months

Job Summary:

  • Bachelor's degree in Computer Science, Engineering, or related field.
  • 8+ years of experience, including 4+ years in technical project management (preferably in SaMD).
  • Proven success in leading cross-functional and multi-site teams.
  • Strong understanding of software development life cycles and medical device regulations.
  • Experience in full-cycle product development-from concept to production launch.

Primary Skills

  • Technical project planning, execution, and integration with broader program goals.
  • Risk and issue management with proactive problem-solving.
  • Strong stakeholder management and communication across teams.
  • High attention to detail and commitment to quality deliverables.
  • Ability to work in fast-paced environments and adapt to changing priorities.
  • Sustaining engineering and project management experience.
  • Metric-driven mindset with a focus on incremental delivery.
  • Experience with Agile methodologies and software development tools.
  • Strong leadership, analytical, and organizational skills.

Secondary Skills / preferred

  • PMP or equivalent project management certification (preferred).
  • Knowledge of medical device regulations and industry standards.
  • Enthusiastic, dedicated, and collaborative team player.
  • Experience in cybersecurity and regulatory compliance for medical software.
  • Familiarity with documentation best practices and knowledge sharing.

"Tekshapers is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law."

Job Tags

Full time, Part time, Internship, Seasonal work, Remote work,

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