Do you have experience within the medical field? Have you worked with Medical Devices previously?
This is an excellent opportunity to join a growing technology company developing new innovations in the field of wearable medical devices.
About the role
KYMIRA is searching for an experienced Medical Device Engineer to lead on all aspects of medical device product development, from concept through to design, prototyping and manufacture.
In this unique role, they will be working predominantly on new e-textile technologies, liaising with a host of different teams, clinical partners, technology supplies and manufactures to deliver KYMIRA’s vision of medical e-textiles. KYMIRA have already conducted early stage research and technical viability and are now looking to take the development to the next stage and create fully certified medical devices. To perform this role, the candidate will need to have strong knowledge and experience working with medical device regulations, such as ISO 13485, ISO 14971, IEC 62304, IEC 60601 and 21CFR820 (knowledge in all is not an essential, but a strong general knowledge and understanding is required).
The ideal candidate would need prior experience gained through research, design and development of medical devices, including a knowledge of risk management and performance or clinical evaluation. The role requires that the candidate be heavily involved in day-to-day technical activities, therefore experience in both software and/or electronics development is also essential. Besides technical design and development, the role will also include the following responsibilities:
- Producing technical documentation (requirements specification, design specification, hazard analysis, traceability analysis, verification and validation) in order to go through Medical Device QMS assessments.
- Advising and mentoring colleagues in areas of competence.
- Lead development of the Design History File
- Help establish internal practices for QMS going forward.
Experience and Education
MEDICAL DEVICE EXPERIENCE IS AN ESSENTIAL FOR THIS ROLE!!
- Degree in Electronic/Software/Biomedical Engineering or similar.
- Strong creative and technical abilities in most or all of the following areas: concept generation, engineering analysis and detail design, design of experiments, design for high & low volume manufacturing.
- Medical device specific regulatory processes and knowledge – ISO 13485, IEC 62304, ISO 14971 and related.
- Proven background in developing medical devices.
- Ability to lead device development projects from start to finish.
- Commercial awareness and knowledge of wearable MedTech trends.
- Experience of working within a commercial setting/or clinical exposure via NHS
- Experience delivering FDA compliant devices including knowledge around related medical device regulation (e.g. 21CFR820).
- Experience with ECG devices, Pacemakers, Implantable cardioverter-defibrillators (ICD) and loop recorders.
Salary: Negotiable (dependent on skills and experience) + lucrative stock options
Type: Full time permanently position.
Location: Office Based in Reading, RG1
To apply, please email firstname.lastname@example.org with a covering letter and CV