This position will be responsible for coordinating new process-product development according to customer specifications, developing hands-on product solutions and supporting the business development cycle. It requires utilizing a collaborative approach to service new partners commercially and supports the new product introduction process for existing partners. It will also require working with a team approach by helping to improve manufacturing methods, systems and processes to produce a high-quality product at optimal cost. The Project Manager aids in managing a complete device project from the early concept, through Nextern’s detailed phase gate development, and through product manufacturing/commercialization.
DUTIES AND RESPONSIBILITIES:
- Coordinates new product development with customers and internal project teams
- Works with engineering team leads and management to create and tracks schedules, budgets, performance targets, resource plans, prioritization and delegation of tasks, and general planning activities for engineering deliverables
- Provides visibility to project schedule and budget issues and manages escalation and coordinates critical issue resolution with project engineering Team Lead, Business Development Manager and Engineering Management
- Provides the project management interface to project leads as well as critical internal and external (client) stakeholders for efficient coordination, execution of critical activities and project management functions
- Ensures good cross-functional communication (through effective meetings, email, and other means) 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 (from internal and external vendors)
- Draft quotations and project scopes for review by management and delivery to customer.
- Help to conduct component and device testing protocols.
- Accurately generates standard written reports.
- Help to develop plans to evaluate process repeatability and stability through equipment qualification and process validation.
- Works with various departments and multiple manufacturing sites to facilitate pilot production of new products.
- Ensures successful completion of project stages gates and related activities required for the projects to comply with the company compliant design and development process
- Ensures 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
- University degree in Ingeneering and desirable post graduate degree and 5+ years in Project Management expetience preferably in medical devices or highly regulated industries.
- PM certification (PMP, Masters degree) is a plus.
- Strong leadership capabilities, managing a high diversity of projects and programs.
- Used to work in complex and challenging environments