Senior Project Manager
⚲ Wrocław
Do uzgodnienia
Wymagania
- Project Management
- Software Development
- Medical device development
- ISO 13485
- Risk Management
- hardware development
- firmware development
- Team Leadership
- Project management certification
- Medical domain awareness
Opis stanowiska
S3 Connected Health is a digital health company headquartered in Dublin, Ireland. Our team of more than 280 clinicians, engineers, behavioural scientists, UX specialists and data experts partners with leading pharmaceutical, biotechnology and medical device companies to develop innovative healthcare solutions that improve patient outcomes and transform healthcare delivery worldwide.At S3 Connected Health, we combine deep healthcare expertise with cutting-edge technology to solve complex challenges in patient monitoring, medication adherence and patient engagement. Our projects span the full spectrum of connected health, from medical devices and embedded systems to mobile applications, cloud platforms and data-driven healthcare services.
As a Connected Health Senior Project Manager, you will lead the delivery of innovative connected medical products across hardware, embedded firmware, mobile and cloud technologies. Working closely with multidisciplinary teams and global healthcare customers, you will drive projects from concept and design through verification, validation, manufacturing transfer and market launch, helping bring technologies to market that make a meaningful difference in patients' lives.
Key Responsibilities
• Working as a Senior Project Manager, you will be responsible for:
• Leading a multidisciplinary project team (or teams) spanning hardware (electronics), firmware, software, quality, and regulatory disciplines to deliver world-class connected medical products from concept through requirements, development, verification and validation, manufacturing transfer, and successful market launch
• Owning the manufacturing readiness path: design for manufacture and assembly (DFM/DFA), tooling and NPI planning, pilot builds, yield and test strategy, and process validation (IQ/OQ/PQ)
• Managing contract manufacturers, ODMs, component vendors, and test houses, including build schedules, cost of goods, supply chain risk, component lifecycle, and quality escalations
• Monitoring all aspects of project development
• Executing projects according to standards: ISO 13485, ISO 14971, IEC 62304, and IEC 60601 series
• Maintaining knowledge on all regulatory issues, especially Medical Device-related (EU MDR, FDA)
• Focusing on software/firmware reliability during the development phases of the products, including rigorous regression testing
• Setting and executing functionality/specification, quality, cost, and timing targets
• Managing the day-to-day activities of the project team members
• Acting as the primary customer contact during the project execution phase
• Risk management
• Regular communication to all stakeholders, both internal and external
• Interfacing with customers on project proposals, specifications, and troubleshooting to provide customer satisfaction
Qualifications required
• Master’s Degree (or equivalent) in Computer Science or related
• At least 10+ years’ experience in people and complex project management/execution
• Strong knowledge of software development processes and PM processes
• Proven track record of successfully delivered projects and market examples
• Outgoing personality and team player capabilities
• Knowledge of the professional software development cycle
• Medical or clinical domain awareness
• Pro-active, open, teamwork approach
• Fluent in spoken and written English
Any of the following is a distinct advantage
• Project Management certifications
• Experience in Medical Device project development
• ISO13485 working experience
Why Join S3 Connected Health?
• Make a meaningful impact by delivering healthcare technologies that improve patients' lives worldwide
• Lead the development of innovative connected medical products spanning hardware, embedded, mobile and cloud technologies
• Work alongside a multidisciplinary team of clinicians, engineers, behavioural scientists, UX specialists and data experts
• Partner with leading pharmaceutical, biotechnology and medical device companies on complex, high-impact programmes
• Grow your career in an organisation that values learning, collaboration, innovation and professional development
• Enjoy a flexible working model with remote, hybrid and office-based collaboration options
As a Connected Health Senior Project Manager, you will lead the delivery of innovative connected medical products across hardware, embedded firmware, mobile and cloud technologies. Working closely with multidisciplinary teams and global healthcare customers, you will drive projects from concept and design through verification, validation, manufacturing transfer and market launch, helping bring technologies to market that make a meaningful difference in patients' lives.
Key Responsibilities
• Working as a Senior Project Manager, you will be responsible for:
• Leading a multidisciplinary project team (or teams) spanning hardware (electronics), firmware, software, quality, and regulatory disciplines to deliver world-class connected medical products from concept through requirements, development, verification and validation, manufacturing transfer, and successful market launch
• Owning the manufacturing readiness path: design for manufacture and assembly (DFM/DFA), tooling and NPI planning, pilot builds, yield and test strategy, and process validation (IQ/OQ/PQ)
• Managing contract manufacturers, ODMs, component vendors, and test houses, including build schedules, cost of goods, supply chain risk, component lifecycle, and quality escalations
• Monitoring all aspects of project development
• Executing projects according to standards: ISO 13485, ISO 14971, IEC 62304, and IEC 60601 series
• Maintaining knowledge on all regulatory issues, especially Medical Device-related (EU MDR, FDA)
• Focusing on software/firmware reliability during the development phases of the products, including rigorous regression testing
• Setting and executing functionality/specification, quality, cost, and timing targets
• Managing the day-to-day activities of the project team members
• Acting as the primary customer contact during the project execution phase
• Risk management
• Regular communication to all stakeholders, both internal and external
• Interfacing with customers on project proposals, specifications, and troubleshooting to provide customer satisfaction
Qualifications required
• Master’s Degree (or equivalent) in Computer Science or related
• At least 10+ years’ experience in people and complex project management/execution
• Strong knowledge of software development processes and PM processes
• Proven track record of successfully delivered projects and market examples
• Outgoing personality and team player capabilities
• Knowledge of the professional software development cycle
• Medical or clinical domain awareness
• Pro-active, open, teamwork approach
• Fluent in spoken and written English
Any of the following is a distinct advantage
• Project Management certifications
• Experience in Medical Device project development
• ISO13485 working experience
Why Join S3 Connected Health?
• Make a meaningful impact by delivering healthcare technologies that improve patients' lives worldwide
• Lead the development of innovative connected medical products spanning hardware, embedded, mobile and cloud technologies
• Work alongside a multidisciplinary team of clinicians, engineers, behavioural scientists, UX specialists and data experts
• Partner with leading pharmaceutical, biotechnology and medical device companies on complex, high-impact programmes
• Grow your career in an organisation that values learning, collaboration, innovation and professional development
• Enjoy a flexible working model with remote, hybrid and office-based collaboration options
🔍 Dekoder Ogłoszenia
🔴
lead the delivery of innovative connected medical products across hardware, embedded firmware, mobile and cloud technologies
Oczekuje się, że będziesz zarządzać złożonymi projektami obejmującymi wiele technologii i dziedzin, co może wymagać szerokiej wiedzy lub umiejętności szybkiego uczenia się.
🔴
drive projects from concept and design through verification, validation, manufacturing transfer and market launch
Będziesz odpowiedzialny za cały cykl życia produktu, od pomysłu do wprowadzenia na rynek, co może oznaczać dużą odpowiedzialność i presję.
🔴
Working closely with multidisciplinary teams and global healthcare customers
Będziesz musiał efektywnie komunikować się i współpracować z różnymi zespołami oraz klientami z całego świata, co może być wyzwaniem ze względu na różnice kulturowe i językowe.
🟢
helping bring technologies to market that make a meaningful difference in patients' lives
Jest to ogólne stwierdzenie motywacyjne, które niekoniecznie odzwierciedla codzienne zadania, ale podkreśla cel pracy.