Product Development Coordinator

hace 2 meses

Paraíso, Paraíso, Costa Rica Nextern A tiempo completo

This position will be responsible for coordinating new process-product development according to customer specifications and driving the development of hands-on product solutions. The role requires 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 to improve manufacturing methods, systems, and processes to produce a high-quality product at optimal cost.

Key Responsibilities:

- Coordinates new product development with customers and internal project teams
- Works with engineering team leads and management to create and track schedules, budgets, performance targets, resource plans, prioritization, and delegation of tasks
- 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 stakeholders for efficient coordination and execution of critical activities
- Reviews design and determines required bill of materials
- Works with supply chain to obtain bill of materials pricing from internal and external vendors
- Drafts quotations and project scopes for review by management and delivery to customers
- Conducts component and device testing protocols
- Generates standard written reports
- Develops plans to evaluate process repeatability and stability through equipment qualification and process validation
- Collaborates 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 project to comply with the company's compliant design and development process
- Ensures proper documentation is completed for each development activity and adequate documentation exists for the Design History File, product manufacturing, and ongoing production documentation
- Performs other related duties as assigned by management

Requirements:

  • Bachelor's Degree in BA or Engineering and five years of related experience in the medical industry
  • Previous experience 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 requests and scope creep
  • Critical leadership competencies, demonstrated ability to work in collaborative environments, and excellence in managing teams and processes

Benefits:

  • Highly competitive package

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