Senior Program Manager-Complex Medical Device

Company Information

At HiArc, we believe clients don’t need another vendor; they need a strategic partner who gets it. One who listens harder, thinks deeper, and builds smarter—around their needs, products, and goals. HiArc engineers and manufactures complex medical technologies with one goal in mind: creating the perfect fit for our clients. No off-the-shelf thinking. No compromises. Just a tailored, high-performance solution our clients need, the way they need it. That’s why HiArc is the most client-centered partner in the market. We fuse design, engineering, and manufacturing into a seamless, collaborative process—crafted entirely around our clients. We operate as an extension of our clients' teams, de-risking their processes and accelerating their path to market. And the result is a solution you won’t find anywhere else.

Join our team! We hire experts in hardware and software design, robotics, optics, fluidics, chemistry integration, motion and thermal control, risk management, supply chain management, performance testing, advanced manufacturing techniques, finance, human resources, sales, and marketing.

For more information, please visit HiArc.

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 successfully, within scope, on time, within budget, and deliver a quality product to the customer’s satisfaction
• Must be an effective communicator, both verbally and in writing
  
  

Here Are Some Of The Great Benefits We Offer

• Most locations offer a 9/80 schedule, providing every other Friday off
• Competitive compensation & 401(k) program to plan for your future
• Robust medical, dental, vision, & disability coverage with qualified wellness discounts
• Basic Life Insurance and Additional Life & AD&D Insurances are available
• Flexible Vacation & PTO
• Paid Parental Leave
• Generous Employee Referral Program
• Voluntary Benefits Available: Longer Term Care, Legal, Identify Theft, Pet Insurance, and more
• Voluntary Tricare Supplement available for military retirees
  
  

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. The employer has the right to revise this job description at any time. The job description is not an employment contract. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. HiArc, an Elbit America company, is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities.

• If you encounter issues with your application, please email TalentAcquisition@ElbitAmerica.com***