Are you an experienced engineer that has a passion for overseeing and documenting the development process for medical devices as per the European MDR? Then perhaps you could be the newest addition to our R&D Function.
We at Uvisa Health are developing a phototherapy (light-based treatment) solution to the common vaginal infections Bacterial Vaginosis (BV) and Vulvovaginal Candidiasis (VVC / Svamp / Thrush). It is a small, insertable device that is intended as a Point Of Care (POC) solution and reusable.
We are ramping up the development phase, which means that a lot of the groundwork has already been done during the concept phase. Now, as we are establishing a manufacturing partnership, soon entering clinical investigations, continuing to enhance the product, and readying ourselves for submission to a Notified Body (NB), we are seeking an experienced professional in this field to continue the work and take a lead within product management.
We are seeking a person who has some mechanical and/or electronics engineering knowledge, experience of documenting medical device product development, and a comprehensive knowledge of the MDR and other regulations applicable to our device such as ISO 13485, ISO 14971, IEC 60601, IEC 62304, etc.
They must be comfortable with working in a startup environment, a self-starter that can manage their own workload and prioritisation of activities, highly structured and organised, and a team player who is able to take on additional roles and responsibilities as required.
They will be reporting to the CEO and this is a full-time role, though working hours are flexible.
We expect that all work is conducted on-site in Copenhagen, Denmark. This is not a remote position.
Applicants will be reviewed on a rolling basis.
Remuneration will be competitive and dependent on experience.
Roles & Responsibilities
- Ensuring compliance to the established Design & Development plans and evolving these as required.
- Managing & structuring information related to the entire product development process and technical file including but not limited to; Risk Management File, Design Input Specifications, Design Output.
- Planning Verification and Validation (V&V) activities, assisting with executing on the plans, and documenting the output of these.
- Working with the Head of Design and the Electronics & Embedded Software Engineer, to contribute expertise to the overall design of the product.
- Producing documentation required for the Technical File and the Clinical Evaluation Plan as required as per the European MDR.
- Working with the QMS and documenting output of processes followed as per ISO13485.
- Project management accountabilities to ensure that deadlines are adhered to and that interdependencies are well managed.
- Additional responsibilities as required as the startup matures.
Qualifications & Competencies
Required
- Minimum Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Electronics Engineering or other related discipline.
- Documented history of working in a similar capacity as eg. R&D Manager, Head of Product Engineering, Systems Engineer, or CTO.
- Comprehensive knowledge of the MDR.
- Previous experience working under ISO13485 for medical devices.
- Fluent in written and spoken English.
- Good initiative (must be able to demonstrate).
Bonus
- Master’s Degree in a related discipline or other professional qualifications within medical device product development.
- Previous experience interfacing with a Notified Body with successful CE certification as a result.
- Experience of working with Regulatory Affairs and/or Quality Assurance.
- Some knowledge of development of light-based technologies and manufacturing processes for these.
