R&D Project Manager

Job Summary

Client is centralizing project management via the establishment of its Transformation Management Office (TMO). This is a unique opportunity to help build this organization from the ground up while immediately jumping in to lead critical medical device projects in the business. In alignment with the client’s strategy and strategic priorities, we are seeking a highly skilled and experienced R&D Project Manager to join our TMO. This role is pivotal is responsible for managing projects, including new product development, design changes, and sustaining or maintenance projects. This position coordinates cross-functional resources and schedules to deliver project plans and deliverables on-time, within budget, and in alignment with company-wide priorities. The R&D Project Manager will work closely with the engineering, regulatory affairs, quality assurance, IT, operations, and supply personnel to facilitate and execute project activities. The R&D Project Manager will ensure that regulatory standards, international registrations, and design control activities are thoroughly planned, documented, and executed to comply with and adhere to best practices in the medical device industry. Reporting to the Vice President (VP) of the TMO, you will significantly contribute to our success and build capabilities and execute programs that shape the future of the company.

Qualifications (Experience and Education)

• Bachelors’ degree in Engineering required.
• Experience in medical device capital equipment development, strongly preferred.
• 5 years’ experience in project management experience, required in medical device or regulatory, required.
• 5 years’ experience managing technical product development required.
• 5+ years of experience as an Engineer developing products, preferably in the medical device industry.
• Knowledge of global standards and regulations for Design Controls, Risk Management, and Electrical Safety for Medical Devices.
• Demonstrated aptitude for successfully managing multiple projects, of varying complexity, within the specified guidelines, timeframes and budgets.
• Demonstrated understanding of electrical, mechanical, and software engineering practices at the system level.
• Exceptional understanding of the product development lifecycle required.
• Project management certification from PMI or equivalent, preferred.
• Fluent in MS Project, Excel and other MS Office applications, required.
• Advanced knowledge/proficiency ISO 13485, MDD or MDR, preferred.
• Advanced knowledge in FDA GMP and ISO regulated quality systems, preferred.
• Knowledge of global regulatory landscape, preferred.
• Strong understanding of technical concepts and ability to effectively collaborate with technical teams.
• Exceptional project management skills, capable of managing multiple projects simultaneously.
• Excellent interpersonal and communication skills, capable of working across various teams and organizational levels.
• Strategic thinking with the ability to align technical efforts with business goals.
• Proficiency in project management tools and software; PMP or similar certifications preferred.
• A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.