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Director of Manufacturing Engineering buy in US, Free Classifieds Ads

ProNova Solutions, LLC is aggressively developing the next generation of cancer therapy technology in a highly integrated proton therapy medical device. The fusion of state-of-the-art imaging, multi-axis precision positioning, superconducting magnet technology, and unprecedented closed loop treatment verification using Positron Emission Tomography sets the ProNova product apart from all others. With this product, our vision is to redefine the future of cancer treatment. We are recruiting team members to help innovate and deliver this vision while also advancing the standard for safety and reliability.

We are currently searching for a Director of Manufacturing Engineering to provide hands on leadership and management for our team of engineers and documentation specialists to start-up and optimize the production processes for the SC360 Proton Therapy System. Additionally, this position will be responsible for designing and implementing DFx improvements on the product and new product or feature introductions. This role is a key member of the Operations Leadership Team and reports directly to the Vice President of Operations.


Primary Duties and Responsibilities for the Director of Manufacturing Engineering:
Lead, guide and direct the manufacturing engineering team as they:
launch production of the SC360 medical device, including process validation
support the transfer of the completed product design from R&D to production
improve the product design and documentation to support manufacturability and servicability
integrate new product features or options into the production processes
develop process and design changes to support cost, quality and delivery improvements
Build the long-term strategic as well as short-term tactical plans to establish and achieve department targets in alignment with company goals
Improve team effectiveness and efficiency by studying, evaluating, and re-designing processes; establishing appropriate channels of communication, monitoring and analyzing results and implementing changes.
Meet financial objectives by forecasting requirements, preparing annual budgets, scheduling expenditures, analyzing variances and initiating corrective actions.

Qualifications/Basic Position Requirements: (education, experience, licenses, etc.)
Bachelor's degree in Engineering; or minimum of 10 years' related experience; or equivalent combination of education and experience. Masters' Degree in Engineering and/or MBA preferred.
Proven ability to lead and manage a high functioning team of mechanical, electrical and process engineers to meet aggressive deadlines and produce tangible results.
Proven success operating within a production environment governed by FDA and ISO13485 Quality System Regulations for Medical Devices.
Proven ability to effectively influence and lead cross-departmentally within the organization as well as with external suppliers or service provides to resolve technical product and process issues.
Excellent documentation skills and proven background with data collection, interpretation and analysis.
Excellent communication skills and ability to clearly convey complex topics to a diverse audience from the shop floor to senior management.
Ability to travel domestically and internationally as required (<20%).


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