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 Sr. 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.
- 5+ years of experience as a Project Manager or similar roles
- Previous experience (minimum of 4 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
Skills Required
- Bachelor's degree in Business Administration or Engineering
- Five years of related experience in the medical industry
- At least five years of experience as a Project Manager or in a similar role
- At least four years of technical experience as a Process or Product Development R&D Engineer in the medical industry
- PMP certification
- Master's degree in Project Management
- Fluent English at B2+ or C1 level
- Ability to provide guidance and mentoring to less-experienced team members
- Experience with FDA 510(k) process or other regulatory submissions
- Ability to manage changing requirements, out-of-scope requests, and scope creep
- Demonstrated leadership, collaboration, and team and process management skills
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
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