Biomedical Engineer (Mechanical)

Position Title: Biomedical Engineer (Mechanical)

Reports to: CEO

Background

Arete Medical Technologies Ltd. (“Arete”) has developed a connected diagnostic and monitoring device that measures lung mechanics and biochemical markers. The device forms the foundation for a digital health layer, for precision management of asthma, COPD, and other long-term lung conditions. These are highly impactful conditions, and haven't yet had the success stories in digital health and precision medicine that heart conditions, diabetes, or cancer have.

We have been successful in multiple, competitive R&D grants totaling about £2 million, including a 1.65 million Euro project that we are the lead collaborator, which had the 2nd highest score of 369 applicants from 34 countries.

We are employing people who value creativity, diversity, and excellence. As a start-up, we need to grow and be adaptable to changing roles within the company. The ability to learn the skills we need for tomorrow are as important as the skills we have today.

The role is for a broadly skilled mechanical or mechatronics engineer. The main part of the role will be mechanical design including CAD (SolidWorks). The role will also involve verification/validation planning, experiments, and documentation. The candidate will preferably also have skills in electronics (such as sensor/component selection and breadboard prototyping, IEC 60601), fluid mechanics (gas flow measurements), software development (python), and medical device technical file development (documentation and processes).

We are based in Cambridge UK and we have an in-person culture. Expected to work 40 hours per week, but flexible working can be negotiated. The role may require occasional travel, mostly within the UK to engage with users and stakeholders along our value chain. There may be opportunities to travel outside the UK including to collaborators or customers.

The position will be a permanent role with a base salary in line with the local market, dependent on experience, and with potential for share options.

We will only consider applications from candidates directly. Direct contact including a message on why you think you are a good fit is encouraged – it will be read and we’ll do our best to respond to all inquiries personally. We are not able to pay recruiter fees. Our funding also requires that the work be done with the person physically in the UK.

Position Overview:

This position will be working with others on the Arete technical team and be responsible in the short term for the majority of the day-to-day mechanical verification and manufacturing design under the guidance of an experienced mechanical engineer on the leadership team. You will maintain the CAD for Arete existing product and lead the mechanical design changes through our design-for-manufacturing efforts. You will be directly coordinating with suppliers (plastics, tooling, metalwork) for feedback and improvement to our design. You will lead on the mechanical verification and validation planning and development of the technical file documentation to medical device standards. Ideally, you will also have skills and desire to contribute to software and/or electronics development.

Medical device development requires excellent technical documentation, experimental design, and time management skills.

Essential Duties and Responsibilities:

· Development of new CAD (SolidWorks) models and maintenance of existing Arete designs through their lifecycle

· Specification of verification and validation tests of the mechanical design, for example to IEC 60601-1

· Documentation of the design, manufacturing, and verification activities within Arete’s ISO 13485 quality management system and ISO 14971 risk management systems

· Prototyping and development of device / sensor calibration protocols and models

· Act as liaison with external vendors such as contract manufacturers and suppliers

· Work with the project manager in project planning and project management; translating high level plans and strategies to the day-to-day project/product execution

Qualifications/Competencies/Position Requirements:

Knowledge, Skills, and Abilities:

· Mechanical design including being an expert in Solidworks CAD, design for manufacture (injection molding), and design for assembly

· Modeling and experiments of fluid dynamics and sensor systems, adjusting the mechanical design to optimize for manufacturing cost and sensing performance

· Development and maintenance of technical drawings and reports

· Specification and selection of mechanical components and suppliers

· Experience working within ISO 13485, ISO 14971, and medical device regulatory frameworks preferred; other regulated industries with willingness to learn medical devices

· Excellent writing and oral communications skills

Desirable skills and abilities

· Software development; (IEC 62304; Python, Kotlin, GitHub)

· Biomedical engineering; technical file development; selection and protocol development of verification tests; usability engineering processes (IEC 62366); risk management processes (ISO 14971)

· Electronics engineering; sensor and other component selection, circuit design, circuit layout (Altium), firmware development (C++)

Higher Education and Experience:

· University degree in Mechanical, Industrial, Mechatronics, Chemical, and/or Biomedical Engineering or related program with 2.1+ and 2-5 years of experience. Recent graduates with exceptional grades and practical projects encouraged to apply.

Or

· Masters/PhD in Mechanical Engineering or related program, preferably with at least 2 years of industry experience

· Experience working in a regulated industry, with strong preference for medical devices