Program Manager

Ezetop LLC; Arlington (VT); On-site; USD 75,000 - 110,000; Full time

Job summary

Mack is seeking a project/program manager to support new business development and lead cross-functional teams in medical device manufacturing. You will coordinate program plans, schedules, and launches while ensuring regulatory requirements and controlled documentation are met.

The role requires a bachelor's degree in engineering or related field, 1–2 years of experience (or 5 years), and strong communication and leadership skills. Travel may be required for customer visits and audits.

Qualifications

• Bachelor's degree in engineering or related field; 1–2 years related experience, or 5 years related experience.
• Ability to read, analyze and interpret technical and regulatory documents.
• Strong project management, scheduling and coordination skills.
• Familiarity with ITAR regulations and controlled environments.
• Ability to lead teams and manage multiple stakeholders.

Responsibilities

• Support new business development and assist outside sales with proposals.
• Coordinate new program planning and launch preparations.
• Lead project teams and establish relationships with customer service.
• Review materials, draft program plans, and pre-production schedules.
• Ensure regulatory requirements are met and documentation is controlled.
• Manage BOMs, CAD files, drawings, and ECR/ECN processes.
• Monitor project scope, schedule, and budget; escalate bottlenecks.
• Communicate project status and risks to management and customers.

Skills

Project management

Leadership

Communication

Budget management

Regulatory compliance

Education

Bachelor's degree in engineering

Tools

CAD

Design software

Word processing

Spreadsheet software

Project management software

Job description

Mack is a leading contract manufacturer, with a dynamic environment for building products needed in our every day world. We build medical equipment, including blood analyzers, centrifuges, photopheresis devices, orthopedic and ophthalmology surgical tools and components, and other cutting-edge medical devices. Exciting products - exciting people!

Essential Duties and Responsibilities

• Support new business development
• Provide support to outside sales to assist with new business development
• Collect information and support preparation of proposal for new business development
• Responsible for coordinating new program planning and launch preparations
• Establish working relationship and leadership with project team members
• Establish working relationships with customer service representatives
• Confirm or define scope of work
• Review customer-supplied program materials, draft program plan and pre-production schedule
• Ensure services performed meet any applicable regulatory requirements
• Communicate the confidential concerns and requirement of an NDA agreement and identify known or potential risks to company making sure all information is controlled in accordance with contractual obligations
• Identify resource requirements
• Identify capital, equipment and NRE requirements
• Define raw material and purchased parts requirements
• Ensure program information is reviewed and entered into company electronic document control system
• Maintain financial tracking and cost management for each program
• Follow phase gate process for product realization
• Ensure Process Flow Diagrams, FMEA and Control Plan are done (as required)
• Schedule and lead program team meetings reviewing program plan and coordinate launch team activities
• Ensure project activity trackers are kept current and published
• Responsible to keep project on schedule and elevate any bottlenecks
• Responsible to keep project at or under budget
• Responsible for all communication with customer on project status reporting
• Confirm and manage all documentation to be complete and controlled in accordance with procedures for example but not limited to bill of materials, drawings, electronic files, specifications, purchase orders
• Ensure customer purchase orders are received, accurate (including review of terms and conditions), invoiced and paid including tooling, capital equipment and NRE/Design services
• Ensure toolmaker and supplier accounts are managed, closed and paid in a timely manner
• Ensure warranty is appropriate for product and components
• Provide project status reports to management
• Responsible for management and growth of existing customer accounts
• Primarily responsible for maintaining account relationship and achieving performance goals, profit and Total Customer Satisfaction
• Continuously monitor program activity to achieve margin targets and to confirm price checks
• Serves as primary customer contact for account management
• Identify and pursue new business opportunities within accounts
• Responsible for business continuity planning and continuous risk assessment specific to customer
• Develop estimates and quotes for new sales opportunities within accounts
• Manage sustaining program information such as 2D prints, 3D files, engineering change orders.
• Manage disposition of obsolete material and slow moving inventory.
• Ensure continuous improvement by challenging functional departments to identify opportunities
• Responsible for customer entertainment and hospitality during on-site customer visits
• Ensure contracts, supply agreements and confidentiality agreements are current
• Coordinate schedule and execution of QBR’s with customer
• Frequent domestic and occasional international travel

Qualifications

• Bachelor's degree (B. A. or B.S.) required, preferably in engineering, plus one to two years related experience. Or five years' related experience.
  
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to lead team members and activity, prioritize and support requirements to meet deliverables. Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• To perform this job successfully, an individual should have knowledge of Word Processing software; Spreadsheet software; Design software; CAD; Order processing systems and Project Management software.
• This role involves working in an ITAR-controlled environment. The successful candidate will have a strong technical background, problem-solving skills, and the ability to work within the strict compliance requirements of ITAR regulations.