Project Manager- Co-Ordinator
About The Position
This role is for a Project Manager- Co-Ordinator located in Austin, TX, requiring an onsite presence. The position involves leading and delivering complex New Product Development (NPD) programs, particularly in the medical device industry, with a focus on robotics, electromechanical systems, embedded software, and cloud applications. The role requires managing project execution, including schedule, budget, risk, and issue resolution, while forming and leading cross-functional teams. Adherence to Agile and DevOps best practices, oversight of cloud-based and connected digital solutions within a regulated medical device environment, and ensuring compliance with design controls, QMS, and medical device regulations are key aspects of this position. The role also involves supporting Design History Files (DHF) and Phase Review governance, providing executive-level reporting, partnering with leadership on product strategy, facilitating various reviews and meetings, and driving the development lifecycle of orthopaedic products from concept to launch. Additionally, the Project Manager will develop detailed project plans, manage sustaining engineering activities, lead cost reduction initiatives, monitor RAID logs, act as a primary point of contact for stakeholders, and coordinate onsite/offsite teams.
Requirements
- Bachelor's or master's degree in biomedical, Mechanical, or related engineering field.
- 10+ years overall experience.
- At least 5 years leading diverse projects in the medical device industry (orthopaedics preferred).
- Project Management certification (PMP, PRINCE2, or Agile PM).
- Proficiency in MS Office, project management tools, and CAD/design documentation.
- Strong understanding of medical device design controls (21 CFR 820.30).
- Excellent communication skills.
- Proactive problem-solving abilities.
- Ability to thrive in fast-paced environments.
- Proven leadership of large, cross functional programs in medical device/MedTech.
- Experience with robotics, electromechanical systems, SaMD, MDDS, IoT, or connected systems.
- Strong knowledge of FDA regulated product development.
- Bachelor's degree in engineering or related discipline.
Responsibilities
- Lead and deliver complex NPD programs involving robotics, electromechanical systems, embedded software, and cloud applications.
- Own project execution including schedule, budget, risk management, and issue resolution.
- Form and lead cross functional teams across engineering, quality, regulatory, manufacturing, and commercial functions.
- Apply Agile and DevOps best practices for software and system development.
- Oversee cloud based and connected digital solutions in a regulated medical device environment.
- Ensure compliance with design controls, QMS requirements, and medical device regulations.
- Support Design History Files (DHF) and Phase Review governance.
- Provide clear executive level reporting on project status, risks, and opportunities.
- Partner with Franchise and Commercial leadership to shape product pipeline and commercialization strategy.
- Facilitate design reviews, requirements reviews, vendor meetings, and cross functional forums.
- Drive the development lifecycle of orthopaedic products from concept to launch.
- Develop detailed project plans, schedules, and budgets, setting timelines for design, verification, and validation.
- Manage sustaining engineering activities, including improvements, enhancements, and design changes.
- Lead cost reduction initiatives while maintaining quality and safety standards.
- Monitor and manage RAID logs (risks, assumptions, issues, dependencies).
- Act as primary point of contact for stakeholders, ensuring regular communication and reporting.
- Coordinate onsite/offsite teams, allocate resources, and ensure timely task execution.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
