Job Description
We are seeking a highly skilled and experienced Senior Manufacturing Project Engineer to lead technical projects in our Medical Device division.
The successful candidate will be responsible for overseeing multiple projects ensuring they are delivered on-time. The ideal candidate will have a strong background in medical device development, with experience in leading cross-functional teams, designing complex systems, and managing technical projects from conception to commercialisation.
Key Responsibilities:
* Lead the development and delivery of medical device projects, from ideation to commercialisation.
* Define project scope, goals, and deliverables, and ensure project timelines are met.
* Collaborate with cross-functional teams, including R&D, quality, regulatory affairs, and manufacturing, to ensure project success.
* Manage project budgets, resource allocation, and risk management.
* Ensure compliance with all regulatory and quality standards, including FDA, ISO 13485, and other applicable regulations.
* Develop and maintain project documentation, including design history files, risk management files, and other project-related documentation.
* Mentor and train other engineers, providing technical leadership and guidance.
Qualifications:
* Bachelor's or Master's degree in engineering, preferably in Biomedical, Electrical, or Mechanical Engineering.
* Minimum of 10 years of experience in medical device development, with at least 5 years in a leadership role.
* Strong knowledge of medical device regulations and quality standards, including FDA, ISO, and other applicable regulations.
* Demonstrated experience in leading technical projects, including project management, risk management, and resource allocation.
* Strong problem-solving skills and ability to design complex systems.
* Excellent communication skills, with the ability to communicate complex technical information to non-technical stakeholders.
* Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously.
* Strong leadership skills, with the ability to mentor and train other engineers.
Our client offers a competitive salary and opportunities for growth and development.
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