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.

We are hoping to have the role as soon as possible, and applicants will be reviewed on a rolling basis.

Remuneration will be in the range of 40,000 - 60,000 DKK per month depending 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.

Uvisa Health jobs

Medical Device Technical File Manager