OneProjects is a start-up based in Dublin (Ireland) and Munich (Germany) developing cutting edge innovative imaging technologies to significantly advance healthcare and solve global unmet clinical needs. With creativity, passion, and focus, we apply our best-in-class engineering and design capabilities to create new hardware, software, and data science technologies. We are looking for an experienced, enthusiastic, and multidisciplinary Manufacturing Manager to join our highly skilled team. OneProjects is in early-stage development of a state-of-the-art Intracardiac imaging system. The system, known as VERAFEYE, incorporates Disposables (intravascular, sterile catheter), Hardware (mechanics, electronics, optics), and Software. The Manufacturing 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 play a critical role in an early-stage startup environment with a dynamic group of innovators, shaping the future of imaging in healthcare.

 

YOUR ROLE WITH US

• Use your knowledge to apply effective and efficient manufacturing processes to the companies’ products and imaging technologies.
• Apply technical excellence and leadership to efficiently achieve high quality manufacturing for new and existing product platforms.
• 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.
• Develop and evaluate manufacturing pilot lines with assistance from staff, technical support and suppliers.
• Take ownership for in-house manufacturing processes and their execution, tool qualification and their maintenance.
• Take ownership for the Device Manufacturing Files (DMF) and Device History Records (DHR) for our products.
• Suggest, contribute, and champion initiatives to improve the manufacturing operations and procedures.
• Provide guidance and review Design-for-Manufacturing (DFM) decisions during the development of our product.
• Exhibit a great attitude as a team player who excels in a demanding start-up environment.
• Understand the company’s quality policy and quality system requirements applicable to tasks.

 

WHAT YOU OFFER

• Hands-on mindset with problem-solving skills and great attention to detail also while multitasking.
• Ability to work in cross-functional teams that span global operations

• Ability to understand technical systems in required detail to develop and maintain their manufacturing processes.
• Track record of at least 5 yrs in developing and establishing of production lines for disposables and reusable hardware (including mechanical, electrical, optical, firmware and software components).
• Experience in DFM and ability to provide suggestions for design improvement to make manufacturing more effective and cost efficient.
• Experience in lean manufacturing and Six Sigma methods.
• Experience with manufacturing of sterile disposables especially intravascular catheters.
• Demonstrated experience in leading internal and external resources to achieve manufacturing goals.
• Strong work ethic with a team-oriented mindset. Previous Startup experience is a plus.
• Openness to live or regularly travel to Munich as part of multiple-use manufacturing and assembly development.
• Excellent communication skills in English and German.

• BE/BEng degree in any technical discipline is required, specifically in process engineering is a plus.

WHAT WE OFFER

• Working in a start-up developing cutting edge imaging systems 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 permanent contract in an award-winning start-up.
• Flexible working environment and an international culture as well as offices in Germany and Ireland.

OneProjects is an equal opportunity employer and welcomes applications from all qualified individuals regardless of ethnicity, sex, disability, religion/belief, sexual orientation or age. Would you like to become part of our team? We would love to hear from you and look forward to receiving your CV and cover letter.