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About Amber Therapeutics
At Amber, our mission is to convert the potential of intelligent bioelectronic hardware (systems that can sense as well as stimulate) into novel bioelectrical therapies.
With an initial focus on the peripheral nervous system, Amber targets disease areas where adding closed-loop intelligence may radically improve clinical efficacy and outcomes.
Our leading indication is a new therapy to treat mixed urinary incontinence, an unmet clinical need that constitutes more than 30% of sufferers of urinary incontinence; a market which affects 5% of the global population and over 60% of elderly women in the Western world.
With venture funding from Oxford Science Enterprises (OSE) and 8VC in the US, alongside Innovate UK grant funding (Biomedical Catalyst), Amber is running an initial in-human pilot study to validate the safety and efficacy of their first therapy.
About the role
We are looking for an exceptional R&D engineer who will contribute to the design and development of a Class III Active Implantable Medical Device. As an early hire within Amber’s engineering team we are looking for a team player able to take responsibility for a broad range of functions and take a transformational approach to their work.
This role requires a strong foundation in engineering principles and the ability to work effectively with a broad range of stakeholders including engineers, clinicians and patients. Specialist knowledge in medical devices or experience working in regulated environments is highly desirable. Limited travel to our clinical trial site in Belgium and partners in Oxford may be required.
Responsibilities
Required
At Amber, our mission is to convert the potential of intelligent bioelectronic hardware (systems that can sense as well as stimulate) into novel bioelectrical therapies.
With an initial focus on the peripheral nervous system, Amber targets disease areas where adding closed-loop intelligence may radically improve clinical efficacy and outcomes.
Our leading indication is a new therapy to treat mixed urinary incontinence, an unmet clinical need that constitutes more than 30% of sufferers of urinary incontinence; a market which affects 5% of the global population and over 60% of elderly women in the Western world.
With venture funding from Oxford Science Enterprises (OSE) and 8VC in the US, alongside Innovate UK grant funding (Biomedical Catalyst), Amber is running an initial in-human pilot study to validate the safety and efficacy of their first therapy.
About the role
We are looking for an exceptional R&D engineer who will contribute to the design and development of a Class III Active Implantable Medical Device. As an early hire within Amber’s engineering team we are looking for a team player able to take responsibility for a broad range of functions and take a transformational approach to their work.
This role requires a strong foundation in engineering principles and the ability to work effectively with a broad range of stakeholders including engineers, clinicians and patients. Specialist knowledge in medical devices or experience working in regulated environments is highly desirable. Limited travel to our clinical trial site in Belgium and partners in Oxford may be required.
Responsibilities
- Contribute to design, development, verification and validation of medical devices.
- Contribute to research activities, including bench testing of new concepts, clinical trial support, analysis of trial data and to manuscript writing. This may involve travel to the trial site to support training activities and data gathering activities.
- To review and nurture IP in the design area.
- Work closely with the engineering team to implement a new quality management system, taking responsibility for agreed areas.
- Plan, test and document work consistent with regulatory expectations for human-use research tools, including 13485-compliant quality management systems.
- Where appropriate, play a key role in the training of new members of the team.
- Continuous improvement of engineering processes and practices within the team
- Adhere to statutory regulations e.g. Health & Safety, IT/data security.
Required
- An excellent academic record with a Masters or equivalent in engineering discipline.
- 2 + years’ experience in relevant area.
- Ability to communicate technical information clearly in written and verbal form to a range of (technical and non-technical) audiences.
- Evidence of working effectively as part of a multidisciplinary research and development team.
- Trustworthy character able to take responsibility for maintaining quality standards in their work.
- Specific subject knowledge and experience within medical device development.
- Experience working within regulated environment, ideally within an ISO 13485 quality management system, with strong understanding of relevant principles.
- Experience working with OEM partners.
- Experience with Notified bodies/FDA and auditing process.
- Experience interacting with clinical colleagues.
- Demonstrate sound work ethics.
- Flexibility to work on a wide range of subject matter depending on the needs of the company.
- Able to actively contribute ideas towards improved ways of working and positive attitude towards change.
- Ability to communicate to stakeholders at various levels, including management, colleagues, consultants, clinicians and patients.
- Team player, looks beyond boundaries of own job to support others and demonstrates strong organisational skills.
- Attention to detail.
- Ability to prioritise work and make decisions.
- Competitive Salary and stock options, depending on experience.
- Flexible / remote working. Time on site (London area) will be expected as the company moves into office space in early 2023.
- 25 days holiday and company pension scheme available.
- Full time.