Job Description

Are you a Development or Process Engineer with experience in either medical devices or a similarly highly regulated industry? If so, we want to hear from you!

Amber Therapeutics are looking for a Development Engineer to join our dynamic team. This is a full-time role based at our custom-built facility in Harwell, Oxfordshire, offering 45,000 - 50,000 per annum. Amber is a pioneering neuromodulation company dedicated to transforming the lives of patients through advanced medical technology. We specialize in the development of cutting-edge active implantable medical devices.

The Role

An exciting opportunity to shape the design and development of active implantable medical devices, this role oversees and optimises production and test processes to ensure efficient, cost-effective manufacturing. You'll work closely with cross-functional teams, develop equipment, drive process improvements and uphold quality and safety standards throughout.

Key Responsibilities:

Support the production team to meet targets and customer requirements. Continuously assess and improve manufacturing processes for efficiency, cost and quality. Lead and support process validation activities, including TMVs and IQ/OQ/PQ authoring, execution and reporting. Apply lean and other improvement methodologies to strengthen operational performance. Collaborate cross-functionally to resolve product or process issues. Partner with Product Development to scale new products from design through to full production. Identify cost-saving opportunities without compromising quality standards and collaborate with Procurement to optimise materials and resource usage. Oversee the maintenance, reliability and safe functioning of production equipment. Use problem-solving techniques (e.g., Six Sigma) to address process challenges & investigate and resolve inefficiencies, equipment issues and quality deviations. Collect and analyse process data using statistical methods to highlight trends &improvements. Ensure processes meet regulatory standards, mitigating risks where required. Maintain accurate and compliant documentation for processes, procedures and any changes made. Manage and coordinate projects linked to process improvements, capacity expansion and new installations. Own QMS documentation, policies and forms relevant to the department.

Skills & Experience

Essential:

Knowledge of medical device (or similarly regulated) development processes including quality and regulatory requirements. Experience executing process validation activities - TMV/IQ/OQ/PQ Experience writing process risk documentation and participating in risk management activities. A detailed understanding of mechanical and electrical engineering, including value stream mapping and process optimisation / improvement Degree level qualification in engineering, science or a strongly related field or equivalent experience.

Desirable:

Strong preference for medical device industry experience Exposure to silicone moulding processes is desirable Experience of electronic assembly and test is desirable Lean Six Sigma Yellow Belt certification advantageous


With solid process engineering experience and strength in authoring risk documentation, you'll be comfortable using project management tools and skilled in solving complex problems. You'll also bring the ability to work effectively with multidisciplinary teams to deliver objectives within agreed timelines.

About Us

Amber Therapeutics is developing a closed-loop neuromodulation therapy able to treat mixed urinary incontinence for the first time and transform the clinical outcome of a very large untreated patient population. Amber's fully implantable PicostimTM System targets the pudendal nerve with a device that can both stimulate and sense physiological responses. Please refer to our website for further information.

What We Offer

This is a chance to be part of a ground-breaking team creating life-changing therapies for millions of people globally. You join us at an exciting phase of our development, as we expand the team and accelerate towards our first Pivotal Trial. In addition, we offer a competitive salary commensurate with experience, private healthcare, income protection, life assurance, company pension scheme and 27 days holiday (plus bank holidays). Amber Therapeutics is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We look forward to hearing from you.



Please note, we plan to shortlist for formal interviews in January, therefore there may be a delay in responding to applications until the New Year.