Project Manager

June 12, 2024

Nextern

Cartago

OTHER

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.

Performs other related duties as assigned by management.

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

We regret to inform you that this job opportunity is no longer available