Project Manager

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