We don’t fill vacancies. We define challenges.
We provide a creative nucleus, open to new ideas in medical product development and in the pharmaceutical industry.
If we share the same values, then we should get to know each other.
In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
And even if there aren’t vacancies at the moment, you should still argue your case because challenging tasks always await good people at Pulmotree.
Jobs
We believe that everything that belongs together also comes together. .
Therefore, we would like to kindly ask external recruiters and headhunters to refrain from making referral proposals.
Chief Technology Officer (m/f/d)
Permanent Employment, Full-time ・ München
Your mission
Important notice: We believe that everything that belongs together comes together. Therefore, we would like to kindly ask external recruiters and headhunters to refrain from making referral proposals.
The Chief Technology Officer will be key to Pulmotree's continued growth and will work with the CEO to make technology strategy decisions at Pulmotree. The CTO will have full disciplinary responsibility for the entire technical sector of Pulmotree including the development and implementation of product portfolio strategies, will drive Pulmotree's patent portfolio, and will be responsible for the technical project management.
The position has responsibility for all device development activities within Pulmotree for European, US and other global markets and includes the supervision of development projects for new products and oversees all related activities like device design, tool development, component manufacture and device performance testing, spanning all phases from initial device concept through to technology transfer, industrialisation and scaling up to commercial manufacture.
The role forms an important section of the company that drives development projects forward to regulatory submissions and commercialisation. Working closely with internal and external fellows the Chief Technology Officer makes sure at all time, cost, quality, regulatory and commercial manufacturing requirements are met. Through the development of strong relationships, this role will be responsible for ensuring high technical standards and timely delivery.
As a key role of the Pulmotree C-Suite, the individual will contribute to the definition and delivery of company objectives, leading by example and driving improvements in culture and systems.
The Chief Technology Officer ensures the standards of work in the technical departments adhere to relevant GMP, data integrity and other global quality standards, working towards readiness for audits, GMP inspections and FDA pre-approval inspections.
Principal Responsibilities
The Chief Technology Officer will be key to Pulmotree's continued growth and will work with the CEO to make technology strategy decisions at Pulmotree. The CTO will have full disciplinary responsibility for the entire technical sector of Pulmotree including the development and implementation of product portfolio strategies, will drive Pulmotree's patent portfolio, and will be responsible for the technical project management.
The position has responsibility for all device development activities within Pulmotree for European, US and other global markets and includes the supervision of development projects for new products and oversees all related activities like device design, tool development, component manufacture and device performance testing, spanning all phases from initial device concept through to technology transfer, industrialisation and scaling up to commercial manufacture.
The role forms an important section of the company that drives development projects forward to regulatory submissions and commercialisation. Working closely with internal and external fellows the Chief Technology Officer makes sure at all time, cost, quality, regulatory and commercial manufacturing requirements are met. Through the development of strong relationships, this role will be responsible for ensuring high technical standards and timely delivery.
As a key role of the Pulmotree C-Suite, the individual will contribute to the definition and delivery of company objectives, leading by example and driving improvements in culture and systems.
The Chief Technology Officer ensures the standards of work in the technical departments adhere to relevant GMP, data integrity and other global quality standards, working towards readiness for audits, GMP inspections and FDA pre-approval inspections.
Principal Responsibilities
- Management and development of Pulmotree Medical's device development, IP, and technical project management department
- lead and oversee a broad network of external experts who are engaged in the development, industrialisation, scale-up and manufacture of Pulmotree’s devices
- Supervising internal and external development projects from concept to product launch
- Participate as a board member in project steering committees, strategic board meetings and partnering steering committees.
- Develop, implement and effectively maintain Pulmotree Medical’s device development processes according to the requirements of the MDR, ISO 13485:2016, GMP and 21 CFR 820
- Ensures the technical departments own up-to-date knowledge of regulatory and quality guidelines relevant to the device aspects, including design control requirements
- Provide training and support to the Pulmotree organisation or external customers
- Represents Pulmotree Medical to external partners and acts as an entrepreneur with focus on business needs
- Identifies and manages risks throughout the business
- Assist with the analysis and resolution of design or manufacturing problems as these arise during the development process.
- Support technical reliability studies and evaluations of engineering design concepts
- Recommend design or test methods and statistical process control practices for achieving required levels of product reliability
- Participate in supplier selection process and specification reviews with suppliers to ensure that purchased items meet specifications
Your profile
- A University degree in a relevant subject or suitable experience in a device development senior management role
- Experienced in the field of Inhalation (Nebulizer, MDI’s, DPIs) and respective combination products
- Very well connected in the respiratory industry
- Excellent knowledge of ISO 13485:2016, MDR, FDA requirements related to medical device development
- Proven track record of managing complex development projects in a highly regulated environment
- Expertise in IP strategy development, design and filing of technical patents
- Knowledge in design control documentation and Quality by Design
- Experienced in Requirements Management (i.e. Requirements Traceability Matrix)
- Wide-ranging expertise in Risk Management, especially in dFMEA and patient risk analyses
- Experienced in the usability of medical devices according to ISO 62366
- Self-motivated and “can do” attitude, a willing to be flexible, with an ability to adapt to change
- Excellent organisational and interpersonal skills and confident in building relationships and liaising at all levels, both internally and externally
- Very good communication skills both in German and English language
Why us?
We provide a creative nucleus, open to new ideas in medical product development and in the pharmaceutical industry.
In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
Apply now In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
Manager Quality Management (m/f/d)
Permanent Employment, Full-time ・ München
Your mission
The Manager Quality Management QM provides leadership across the business within a highly regulated medical devices and combination product environment. The Manager QM will be responsible to develop the Pulmotree Medical Quality Management System according to the ISO 13485:2016 standards / FDA / GMP requirements.
Your key responsibles will be:
Your key responsibles will be:
- Develop, implement and effectively maintain Pulmotree Medical’s QM System according to the requirements of the MDR, ISO 13485:2016, GMP and 21 CFR 820
- Act as a quality management representative, irrespective of other responsibilities, with the responsibility and authority that includes:
- Ensuring that processes needed for the quality management system are documented
- Reporting to top management on the effectiveness of the quality management system and any need for improvement
- Ensuring the promotion of awareness of quality management system requirements throughout the organization
- Represents Pulmotree Medical within QM responsibilities to external partners and acts as an entrepreneur with focus on business needs
- Responsible for ensuring PULMOTREE's business activities are conducted in compliance with the regulations and standards applicable to our business and product range
- Ensure Pulmotree’s product lifecycle activities meet the quality management requirements of applicable global markets
- Responsible for the planning and hosting internal and external Quality audits
- Develop and maintain standard operating procedures or local working practices
- Provide QM guidance to customers, departments or development project teams regarding design, development, evaluation, or marketing of products
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations
- Supporting management through active risk management
Your profile
- A Diploma or Master degree in a relevant subject and/or suitable experience in a QM role
- Excellent knowledge of ISO 13485, MDR, FDA requirements
- Experienced in the development, implementation, and maintaining quality management systems
- Proven track record of preparing and managing successful quality audits (internal/external) and inspections
- Very good communication skills both in German and English language
Please take into account that the place of work is Munich and a permanent work permit is required.
Why us?
We provide a creative nucleus, open to new ideas in medical product development and in the pharmaceutical industry. If we share the same values, then we should get to know each other.
In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
Apply now In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
Project / Program Manager (m/f/d)
Permanent Employment, Full-time ・ München
Your mission
Important notice: We believe that everything that belongs together comes together. Therefore, we would like to kindly ask external recruiters and headhunters to refrain from making referral proposals.
The Project / Program Manager (m/f/d) is accountable for leading our cross functional team in the execution of multiplef projects focused on the development of our drug delivery devices portfolio and our partnering programs for combination products.
Principal Responsibilities
The Project / Program Manager (m/f/d) is accountable for leading our cross functional team in the execution of multiplef projects focused on the development of our drug delivery devices portfolio and our partnering programs for combination products.
Principal Responsibilities
- Provide project and program management activities for one or more product development programs.
- Coordinate and drive development process planning activities including integrated development plans, budget inputs and go/no go criteria as appropriate.
- Work closely with the relevant management team to facilitate the elaboration, approval and execution of the global program and project strategy, as well as facilitate decision-making processes.
- Working independently, provide best in class operations and program management expertise to drive project team members towards excellence in execution.
- Maintain the overall development plans and enterprise portfolio inputs.
- Implement development plans by managing project teams, track project timelines and budget, drive team meetings/agendas/minutes including drive and track ‘actions’ and facilitate team goal setting and tracking to ensure adherence to plan and strategy.
- Issue and present reports to senior management on a routine basis.
- Help ensure consistent practices throughout all phases of the project life cycle.
- Applies best practices in the development, initiation, planning, execution, control and closing of projects.
- Interacts with all departments to ensure project information is reviewed and maintained.
- Contribute to developing the programme and project management processes used in the business, act as an advocate within the business for the agreed structured approach.
- Act as a key contact for PULMOTREE with external partners.
- Work effectively across cultural and scientific boundaries.
Your profile
- A University degree in a relevant subject or suitable experience in a device development
- Owns ideally a project management certification (i.e. IPMA)
- Experienced in the field of Inhalation (Nebulizer, MDI’s, DPIs) and respective combination products
- Experience facilitating/ leading multi-disciplinary teams
- Strong understanding and competency in planning processes and decision making.
- Demonstrated experience using standard program management tools and software including integrated development plans, timelines, risk management, and budget development and monitoring.
- Minimum of 5 years working experience, at least 2 years of that as a project manager / program manager.
- Proven track record of managing complex development projects in a highly regulated environment
- Knowledge in design control documentation and Quality by Design
- Experienced in Requirements Management (i.e. Requirements Traceability Matrix)
- Expertise in Risk Management, especially in project risks, dFMEA, pFMEA and patient risk analyses
- Knowledge in the usability of medical devices according to ISO 62366
- Self-motivated and “can do” attitude, a willing to be flexible, with an ability to adapt to change
- Excellent organisational and interpersonal skills and confident in building relationships and liaising at all levels, both internally and externally
- Very good communication skills both in German and English language
Why us?
We provide a creative nucleus, open to new ideas in medical product development and in the pharmaceutical industry.
In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
That means for example:
Apply now In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
That means for example:
- Work in a professional and performance-oriented environment in international teams
- Freedom to develop your own ideas and drive them forward
- A fantastic team and a great place to work in our brand new Munich office
- Espresso, drinks, lunch allowance and other social benefits
- And of course an attractive salary
Regulatory Affairs Manager (m/f/d)
Permanent Employment, Full-time ・ München
Your mission
The Regulatory Affairs managers provides regulatory affairs leadership across the business within a highly regulated medical devices and combination product environment. This role will be particularly responsible for:
• Implement and maintain regulatory affairs policies and procedures to ensure regulatory compliance
• Provide regulatory guidance to the development teams
• Preparation and submission of new products i.e. 510(k) or in declaring CE conformity
• Monitoring regulations, guidelines, and standards
• Implement and maintain regulatory affairs policies and procedures to ensure regulatory compliance
• Provide regulatory guidance to the development teams
• Preparation and submission of new products i.e. 510(k) or in declaring CE conformity
• Monitoring regulations, guidelines, and standards
Your profile
- A Diploma or Master degree in a relevant subject and/or suitable experience in a regulatory role
- Excellent knowledge of MDR, FDA requirements, with experience in supporting regulatory submissions
- Extensive knowledge of combination product requirements to support i.e. New Drug Applications (NDA)
- Regulatory requirements for medical devices, medical software, and combination products
- Experienced in risk management according to ISO 14971
- Proven track record of preparing and managing successful quality audits (internal/external) and inspections
- Very good communication skills both in German and English language
Why us?
We provide a creative nucleus, open to new ideas in medical product development and in the pharmaceutical industry. If we share the same values, then we should get to know each other.
In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
Apply now In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
Unsolicited applications
Permanent Employment, Full-time ・ München
Your mission
Haven't found a suitable position? Here you have the opportunity to have your application marked for future vacancies. Who knows, maybe you can even create a new position with your application, because your personality simply blows us away.
Your profile
In our young team, everyone can, and should, take on responsibility. In a dynamic environment, you can show what you can do and who you are because ability and character are more important to us than hierarchies and titles.
Apply now