Program Manager at Tegra Medical Holdings LLC

Franklin, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Aug, 26

Salary

133000.0

Posted On

21 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Planning, Budget Management, Resource Allocation, DFM, Risk Management, Stakeholder Communication, Cross-functional Leadership, ISO 13485, FDA Quality System Regulations, Microsoft Project, CAD Software, Medical Device Manufacturing, Clean Room Operations, Sterilization, Injection Molding, Insert Molding

Industry

Medical Equipment Manufacturing

Description

Job Summary The role of the Program Manager is to plan, execute, and finalize projects according to strict deadlines and within budget. This includes acquiring resources and coordinating the efforts of team members and third-party contractors or consultants to deliver projects according to plan. The Program Manager will also define the project’s objectives. Role and Responsibilities · Responsible for the planning, coordination, development and closure of the different projects that are managed in the company, in addition to the maintenance of all these data so they can be easily visualized by the rest of the management staff and project teams. · Assume and develop a practical approach to the control and visualization of projects. · Procure, coordinate and monitor that the technical resources of each project are supplied and executed according to the established schedule. · Supervise and ensure that the execution of the projects are developed under the established on the Project Plan. · Plan the transfer of new products from development to the Industrialization team, including the development of the transition plan. · Main point of contact regarding new product development projects; actively participating with the new product teams. · Provide manufacturing support (DFM) with direct customer interaction. · Responsible for the project schedule. · Provide technical solutions as needed. · Advance or, where appropriate, resolve the different difficulties that may arise in the execution or development of the project, taking the necessary and feasible corrective action for the fulfilment of the agreed objectives. · Create/ edit/ request/ verify and maintain all the necessary documentation in each of the developed projects. · Direct and manage project, day-to-day operational aspect of a project and scope, including schedule updates, availability of raw materials, correct storage, environmental impact of the installation, resource allocation, cost tracking, delivery times, among others; minimizing exposure and/or risks in project. · Collaborate with Quality area establishing policies, procedures, and accountability measures that ensure regulatory compliance and continuous performance improvement. · Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders. · Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion. · Liaise with project stakeholders on an ongoing basis. · Draft and submit budget proposals and recommend subsequent budget changes where necessary. Keep a strong and friendly communication with the main people into the project (manager, team, stakeholder, etc.) to negotiate acquisition of required staff, time, machinery or any other needs of the project. · Set and continually manage project expectation with team members and other stakeholders. · Delegate tasks and responsibilities to appropriate personnel. · Identify and resolve issues and conflicts within the project team. · Plan and schedule project timelines and milestones using appropriate tools. · Develop and deliver progress reports, proposals, requirements documentation, and presentations. · Determine the frequency and content of status reports from the project team, analyzing the results, and recommending a troubleshoot for affect areas. · Proactively manage changes in project scope, identify potential crises, and devise contingency plans. · Define project success criteria and disseminate them to involved parties throughout project life cycle. · Coach, mentor, motivate and supervise project team members and contractors, and influence them to take positive action and accountability for their assigned work. · Establish close commercial relationships that favor the growth of the business and the success of the projects. · Develop best practices and tools for project execution and management · Comply with the standards and procedures in good manufacturing practices, occupational health, quality and production established by the company. · Support and cultivate a work environment in the company, stimulating proactivity, continuous improvement and good relationships between department and collaborators. · Carry out the other duties assigned by the immediate superior and which are related to the nature or its positions. Qualifications and Education Requirements A degree in Engineering and at least 5 years engineering experience in a medical device-manufacturing environment is required. Must have experience with Class II & Class III finished medical devices. Experience with packaging, sterilization, and exposure to clean room injection and insert molding. Should have experience in managing product and process developments as well as the ability to lead programs that involve manufacture of medical components and devices. Must possess a pro-active attitude and provide leadership and project management to a cross-functional team and assist in directing them in achieving assigned goals and objectives. Must be a self-motivated, hands-on individual with a strong sense of urgency and passion for the customer. Must have the ability to react quickly to changing requirements and new processing developments as well as have a keen interest in quickly learning and applying new skills. Excellent written, oral and verbal communication English skills are required. Experience with Microsoft Project and CAD software preferred. Experience with ISO 13485 standard and/or FDA Quality System Regulations is a must. Physical Requirements: · Frequent performing repetitive work · Occasional lifting (max. 40 lbs.) · Occasional carrying (max. 40 lbs.) · Subject to physical hazards from moving equipment and machine parts · Constant safety glasses · Constant full PPE · Frequent standing · Occasional sitting, walking, pushing, pulling, reaching M-F Standard Office Hours

Responsibilities

The Program Manager is responsible for planning, executing, and closing medical device projects within budget and strict deadlines. This includes coordinating technical resources, managing product transfers to industrialization, and ensuring regulatory compliance.