Project Specialist II

Artech

Job Title: Associate Project Manager
Job Id: 19474-1
Duration: 12 Months
Location: Valencia, CA 91355 (Hybrid)
Pay Range:$65.00 - $67.11/hr on W2

Top Skills

2-4 years of Project/Program Management experience in software medical devices or other regulated industries.
Experience managing software development projects (planning, execution, V&V, SDLC).
Knowledge of IEC 62304, ISO 14971, ISO 13485 , FDA/EU MDR, and cross-functional coordination.

Key Responsibilities

Manage software product development projects from planning through execution.
Develop and maintain project plans, schedules, budgets, risks, and status reports.
Coordinate with R&D, Quality, Regulatory, IT, Cybersecurity, Clinical, and Operations teams.
Support software lifecycle activities including requirements, risk management, V&V, cybersecurity, design reviews, and regulatory submissions.
Drive issue resolution, stakeholder communication, and process improvements while ensuring quality and compliance.

Required Qualifications

Bachelor's degree in Engineering, Computer Science, or related field.
2-4 years of Project Management experience in regulated software/medical device environments.
Software engineering background with medical device experience.

Preferred

FDA, EU MDR, cloud-connected devices, cybersecurity, or mobile health experience.
PMP, Agile, PgMP, or SAFe certification.

Vacancy posted 1 hour ago

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