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Operations Development Manager
hace 1 mes
This is an exciting opportunity to join Nextern as a Project Manager, where you will play a crucial role in driving new process-product development according to customer specifications.
As a key member of our team, you will be responsible for coordinating with internal project teams and customers to ensure seamless execution. Your expertise in developing hands-on product solutions will support the business development cycle.
Key Responsibilities- Coordinate new product development with customers and internal project teams.
- Work with engineering team leads and management to create and track schedules, budgets, performance targets, resource plans, prioritization, and delegation of tasks.
- Provide visibility to project schedule and budget issues and manage escalation and coordinates critical issue resolution with project engineering Team Lead, Business Development Manager, and Engineering Management.
- Ensure 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.
- 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 requests and scope creep.
- Critical leadership competencies, demonstrated ability to work on collaborative environments, and excellence in managing teams and processes.
The estimated salary for this role is $120,000 - $150,000 per year, depending on experience. Nextern offers a highly competitive package, including benefits that support your well-being and career growth.