This position will be responsible for coordinating new product development according to customer specifications, developing hands-on product solutions and supporting the business development cycle for Nextern. 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 Senior Project Engineer 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: Define project objectives, project scope, roles and responsibilities. Define resource requirements and manage the availability and allocation of resources, both internal and third-party. Outline a budget based on requirements and track costs to deliver the project within budget. Prepare a detailed project plan to schedule key project milestones, deliverables, workflows, and activities. Manage project delivery according to this plan. Provide project monitoring and provision of regular project status reports to the project team and key stakeholders. Manage and adjust any changes to the project scope, schedule, and/or budget. Identify and mitigate potential risks. Manage the relationship and communication with the client and all stakeholders, ensuring that the project is delivered to their satisfaction. Develop all standard operating procedures required for project management. Generate the governance process for the projects assigned by the company. Develop the necessary KPIs to measure project performance. Evaluate the resource requirements for the successful execution of projects. Comply with CGMP and ISO/FDA requirements. Review and approve all raw material change order documents. Maintain accurate purchasing master data, AVL, records information, etc. Generate the interface with the areas of Operations, quality and other areas that apply to ensure timely performance and adequate prioritization of the materials received. Serve as a communication channel with customers. Ensure on-time deliveries with customers Align with the Production area to understand the requirements of the customers and that the activities are aligned to meet them. Ensures good cross-functional communication (through effective meetings, email, and other means) to ensure coordination between Engineering functional areas and other departments. Performs other related duties as assigned by management. Requirements Bachelor's degree in engineering and five years of related experience and/or training, or equivalent combination of education and experience. 3 years or more of experience in highly regulated industries such as pharmaceutical, medical devices is desirable Advanced English level Advanced Microsoft Office Knowledge Commitment to excellence and high standards Excellent written and oral communication skills Strong organizational, problem-solving, and analytical skills Ability to manage priorities and workflow. Ability to coordinate and flexibility to attend meetings across multiple time zones (Asia/Americas) Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm. Acute attention to detail Demonstrated ability to plan and organize projects. Proven ability to handle multiple projects and meet deadlines. Benefits Competitive compensation package
