Manufacturing Program Manager

Manufacturing Program Manager is required by CareerWise Recruitment for our Galway based start-up client. This role will require the right person to work on-site with our manufacturing partners in West of Ireland & Mainland Europe on a regular basis. The Manufacturing Program Manager will be responsible for developing, implementing, and maintaining world-class manufacturing processes for our products together with contract manufacturers and internal resources. You are going to provide guidance, establish appropriate process controls while fulfilling our business needs, relevant standards, and regulations. As part of your role, you will oversee the design transfer process and scale up of Manufacturing and play a critical role in an early-stage start-up environment with a dynamic group of innovators, shaping the future of imaging in healthcare. #hybrid

THE ROLE:

• Develop and Manage effective and efficient manufacturing processes to the companies’ products and imaging technologies including Materials planning, Production Scheduling and Product release for Use
• Partner with R&D on new Product Development including Design-for-Manufacturing (DFM) & Design Transfer to internal and/or contract manufacturing operations
• Develop good working relationships and partnerships for effective management of 3rd Party Manufacturing partners
• Openness to regularly travel to Company & 3rd Party Manufacturing Sites
• Prepare, present, and lead formal/informal reviews of manufacturing development, challenges, and production analyses, and drive alignment with peers, project team, and cross-functional stakeholders.
• Ownership for Manufacturing records including DMR and DHR for our products.
• Understand the company's Quality Policy and Quality System Requirements applicable to tasks.
• Create and manage annual budget for Manufacturing activities.
• Capacity & Financial modeling for scaling up production capacity including COGS
• Exhibit a great attitude as a team player who excels in a demanding start-up environment.
• Promote and support a continuous improvement culture and drives cost saving initiatives.
• Provide strong integrity, vision, knowledge, and overall aptitude to the organization.

REQUIREMENTS:

• Bachelor’s degree in engineering or related specialty with a minimum of 10 years’ experience with at least 5 years in a leadership role in a Regulated industry.
• Experienced in working within ISO 13485/FDA regulated quality systems with understanding and application of risk management methodology.
• Ability to work effectively in cross-functional & cross-organisational teams that span global operations, building effective relationships and leading internal and external resources to achieve manufacturing goals.
• Experience in DFM & Lean manufacturing and Six Sigma methods.
• Experience with manufacturing of sterile disposables especially intravascular catheters is desirable and Hardware is a plus
• Strong work ethic with a team-oriented mindset. Previous Startup experience is a plus.
• Possess a flexible, pro-active approach to problem solving, be an adept negotiator and apply risk-based decisions
• Strong organizational, communication, interpersonal, managerial and leadership skills

WHAT WE OFFER:

• Working on cutting edge imaging systems to the direct benefit of patients and improving healthcare.
• Becoming part of a dynamic, multi-national team of highly skilled individuals with a very strong focus on team culture and individual development.
• A learning environment where you can extend and build upon your skills and interests.
• Flexible working environment and an international culture as well as offices in Germany and Ireland.