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HiArc · 11 hours ago

Operations Program Manager II

Merrimack, NH

Full-time

Onsite

Mid, Senior Level

6+ years exp

HiArc is a company that engineers and manufactures complex medical technologies focused on creating tailored solutions for clients. The Operations Program Manager II will act as the main point of contact between HiArc and customers, managing product introduction and sustaining engineering projects while ensuring project success and customer satisfaction.

Health CareInformation TechnologyManufacturingMedical

Responsibilities

Act as main point of contact between HiArc 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

Qualification

Program ManagementFDA RegulationsMedical Device DevelopmentISO 13485PMP CertificationLeadershipCross-functional CollaborationTechnical Reporting

Required

A Bachelor's degree in Engineering and/or Operations with 3+ years of functional experience and 3-5 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