Operations Program Manager – Medical Device Manufacturing (REF2123G)

Operations Program Manager Medical Device Manufacturing (REF2123G)

KMC Systems, an Elbit Systems of America company, offers an ecosystem of engineering and innovation to develop the most advanced clinical and operational solutions for leading medical device customers across a diverse range of market segments.

KMC was established in Merrimack, NH, in 1980, conveying almost half a century of innovation, R&D of next generation devices, and the agility to evolve to meet changing market dynamics.

This has kept KMC at the forefront of technological advancements and as the premier choice for leading global medical device and healthcare companies.

KMC is a full-suite provider with services in : Engineering Design, Manufacturing, Product Ideation, Product Lifecycle Management, and Sustaining Engineering.

You can get further details about the nature of this opening, and what is expected from applicants, by reading the below.

We are looking for extraordinary people to join #OneTeamOneMission to create and deliver innovative solutions that protect and save lives

The Operations Program Manager (OPM) will act as the main point of contact between KMC and our customer, focused specifically on the build to print and sustaining activities within operations.

Included scope for this Program Manager includes managing transitional efforts for new product introduction, and the planning and execution of existing sustaining engineering projects, focused on maintaining continuity of supply and cost reduction initiatives, in addition to establishing and coordinating cross-functional preparation for regular business reviews i.

e. Steering Committee, Monthly meetings & Quarterly Business Reviews. This encompasses direction of a disciplined engineering team, monitoring all aspects of program performance and authority to make decisions to assure the success of the project from inception to completion.

This position involves the application of complex electronics, optics, mechanisms and software to advanced medical instruments.

As part of assuring customer satisfaction is maintained, program cost and project schedules are adhered to, the incumbent will lead a team of Engineers allocated to support the program while interacting with quality, manufacturing, materials, marketing, and finance departments also.

• Act as main point of contact between KMC and our customer, ensuring PO coverage is maintained, and Production schedule commitments are communicated
• Manage the planning and execution of sustaining engineering projects, focused on maintaining continuity of supply and cost reduction initiatives.
• Interface regularly with Product Marketing, R&D Continuation Engineering, Supply Chain, and Procurement Engineering functional areas
• Create and maintain product portfolio roadmap detailing the sustaining efforts required over the lifecycle of each product.
• Provide leadership to engineering staff regarding project prioritization and execution.
• Provide project management for sustaining projects.
• Implement and manage resource planning and project management tools.
• Coordinate, select and schedule project engineers for Operations projects.
• Support continuing production, process development and new product introductions.
• Participate in cross-functional teams.
• Prepare technical reports, analysis, recommendations and presentations reflecting the status and results of projects in progress on a regular basis.
• Drive continuous improvement of engineering technical capabilities.
• Monitor and evaluate project and department progress and results.
• Ensure a safe work environment consistent with OSHA requirements and Abbott policies.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Minimum Requirements :

A Bachelor's degree in Engineering and / or Operations with 3+ or more years of Program Management experience to be proficient in the above areas;

or an equivalent combination of education and experience.

• Requires a track record of successful program management for complex, electro-mechanical products in a dynamic environment.
• Must have experience in an FDA regulated environment and have developed medical devices and / or instrumentation.
• Should be familiar with ISO 13485.

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