Project Manager
hace 1 mes
This is a challenging role that requires a strong background in project management, engineering, and product development. As a Project Manager at Nextern, you will be responsible for coordinating new product development, managing project schedules and budgets, and ensuring the successful completion of project stages gates.
Key Responsibilities:
- Coordinate new product development with customers and internal project teams
- Work with engineering team leads and management to create and track schedules, budgets, and performance targets
- Provide visibility to project schedule and budget issues and manage escalation and critical issue resolution
- Ensure good cross-functional communication to ensure coordination between Engineering functional areas and other departments
- Review design and determine required bill of materials
- Work with supply chain to obtain bill of materials pricing
- Draft quotations and project scopes for review by management and delivery to customer
- Help to conduct component and device testing protocols
- Accurately generate standard written reports
- Help to develop plans to evaluate process repeatability and stability through equipment qualification and process validation
- Work with various departments and multiple manufacturing sites to facilitate pilot production of new products
- Ensure successful completion of project stages gates and related activities required for the projects to comply with the company compliant design and development process
- Ensure proper documentation is completed for each development activity, and that adequate documentation exists for the Design History File, product manufacturing and ongoing production documentation
Requirements:
- Bachelor's Degree in BA, Engineering and five years of related experience in the medical industry
- Previous experience (minimum of 2 years) in the technical field as a Process and/or Product Development R&D Engineer in the medical industry is a plus
- PMP Certification and/or a master's degree in project management is a plus
- Fluent English 85-90% B2+ or C1
- Able to provide guidance and mentoring to less-experienced team members
- Experience with FDA 510(k) process or other regulatory submissions preferred
- Adaptable to changing requirements and expectations but capable of identifying, communicating, and managing out of scope request and scope creep
- Critical leadership competencies, demonstrated ability to work on collaborative environments and excellence in managing teams and processes
Benefits:
Highly competitive package
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