TidalSense is a respiratory technology company with a mission to transform the diagnosis, monitoring and management of chronic respiratory conditions, such as asthma and COPD. The company has ambitions to enable a population-scale change in respiratory care through global deployment of its technologies. TidalSense is about to launch the first-of-its-kind AI-driven (software medical device) diagnostic test for COPD which uses the company’s unique, patented, sensor technology embedded in the N-Tidal device.
We are seeking aProject Manager with strong technical expertisetosupport our engineering teams to deliver key growth initiatives for the business. We are at an exciting phase in our journey as we transition from a start-up to a scale-up. You will be joining a passionate, socially-motivated and multi-disciplinary team covering engineers, scientists, clinicians, designers, product and usability specialists. This is a unique opportunity for a driven and autonomous individual tomanage the technical development of a new generation of regulated hardware and software medical device productsto deliver impact in the real world and change people’s lives. We are seeking someone who is comfortable working in a fast-paced, agile, and diverse team environment, and who is also committed to our mission to revolutionise respiratory medicine
Requirements
Job purpose
To plan, organise, and direct projects associated with medical device research, design and development, design transfer, and launch, ensuring these projects are on time, within budget, and within scope.
Key duties & responsibilities
- Lead the planning and implementation of research, design and development, design transfer and product launch projects, ensuring projects are completed according to outlined objectives (including regulatory compliance)
- Develop detailed project plans to track progress and optimise delivery, ensuring that all projects are delivered on-time, within scope and within budget
- Manage changes to project scopes, project schedules and project costs using appropriate verification techniques and with appropriate sign off
- Manage project performance, issues and risks, creating mitigation plans and escalating to appropriate stakeholders as necessary
- Establish trust with a variety of internal and external stakeholders, addressing concerns and conflicts to remove resistance to progress
- Run project / sprint planning sessions, bringing relevant team members together for sprint reviews and retrospectives, setting targets, objectives, owners and delivery dates and managing the backlog
- Create and maintain appropriate and effective project documentation for planning, regulatory compliance, risk management and knowledge capture
- Conduct post-project evaluations and identify and implement improvements to products and processes based on these insights
- Provide operational and project management oversight on medical device technical file building, maintenance and post-market activities.
Skills & Competencies
Essential:
- Advanced user of Jira
- A strong understanding of what it takes to create and launch new products including understanding software development practices, operations and the inter-connectivity of different functions, and demonstrating regulatory compliance
- Ability to create a clear project plan from ambiguity and manage uncertainty; you are not intimidated by complex problems and are proactive and pragmatic when it comes to solving them
- Strong communication skills - ability to influence effectively across levels and functions
- Excellent organisational skills and attention to detail
- Resilience and flexibility to work in a busy and changing / dynamic environment with ability to deal with workload peaks and troughs
- Proficient with Microsoft Office and Sharepoint
Qualifications & Experience
Essential:
- Bachelor's degree or above
- A track-record of delivering projects through collaborative teamwork
- Experience with requirements, risk management and agile / scrum methodologies
- Experience working with: medical devices (including within an ISO 13485 quality management system), regulatory affairs specialists, and technical teams to manage the build of medical device technical files
- Experience in software project or product management
- Experience of managing projects through design phase and design change processes
Desirable:
- Certified Agile Project Manager / Scrum Master
- Knowledge of UK, EU and US medical device regulatory requirements
- Experience working with the following standards: IEC 62304, 60601-1, ISO 14971
- Experience working as a software engineer in industry
- Experience in managing projects for launch in multiple international markets
Other Requirements
- Legally eligible to work in the UK without sponsorship
- Will need to be able to work in person in the Cambridge office at least 2 days / week.
Note to Applicants
- We read all applications carefully, including free-text answers in evaluating your application. Please make sure you spend some time answering these questions carefully.
- Please answer questions truthfully. Dishonesty is fundamentally against our values.
- We appreciate that some candidates may hesitate to apply because they may feel that they might not meet the required criteria or be competitive enough. If this is you, please don't shy away from applying - we would like to hear from you.
Closing date for applications:Sunday 9th February 2025
Benefits
- Flexible working hours to support your work preferences
- Hybrid working as per requirements above
- Beautiful award-winning Cambridge UK office stocked with quality drinks & snacks
- Work from abroad for 1 week per year
- Buy / sell up to 5 days annual leave
- Generous individual personal development budget + dedicated development days
- Mental Health support: wellbeing support and free 24/7 access to qualified counsellors and advisors
- Wellness budget
- Coaching and mentoring
- Team events and celebrations
- 25 days annual leave + 8 public holidays
- Pension: TidalSense contributes 5% of qualified earnings (actively looking to increase this)
- Annual performance-based bonus
- Discretionary share options scheme
Salary
TidalSense operates a fair pay structure to ensure our colleagues are paid equitably and competitively for their skill, expertise and experience. Successful candidates will be offered this role at the appropriate grade, based on both their resume experience and our judgement of their performance level through the assessment process.
