Senior Program Manager-Complex Medical Device

Job Summary:

The Program Manager will focus specifically on R&D activities.

This Program Manager will manage ongoing development efforts for new product design, focused on innovative solutions that complement HiARC's core technologies.

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.

Oversees a team and interacts with quality, manufacturing, materials, marketing, and finance departments.

Acts as a point of contact with internal customers.

Assures customer satisfaction on project schedules, instrument technical performance, and program cost.

Responsibilities and Tasks :


* Manage the planning and execution of engineering projects, focused on innovative solutions that complement HiARC's core technologies.


* Interface regularly with Product Marketing, R&D Continuation Engineering, Supply Chain, and Procurement Engineering functional areas


* Create and maintain a 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


* 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.

Qualifications :


* A bachelor's degree in engineering; a master's is preferred


* 3 plus 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 engineering activities in a dynamic environment


* Must have experience in an FDA-regulated environment


* Must have developed medical devices and/or instrumentation


* Should be familiar with ISO 13485


* Demonstrated ability to complete programs...