Medical Device Engineer
Fixed Term (12-month Maternity Cover)
Cambridge, UK
Up to £60,000 per annum
Background:
Endomag is the global technology company that believes everyone deserves a better standard of cancer care. Many of the world’s leading physicians and hospitals use our magnetic-based technologies to help women with breast cancer avoid surgery when it isn’t needed, and experience better outcomes when it is. Using our Sentimag® probe, physicians are able to accurately stage breast cancer with our Magtrace® lymphatic tracer and perform tissue localisation procedures with our Magseed® marker.
So far, our team has helped over 200,000 women around the world access more precise and less invasive breast cancer care. Now, we’re looking for a Contract Medical Device Engineer to help us continue to deliver on our promise and play a critical role in our mid to late stage of one of our new product developments. If you are passionate about improving cancer care around the world and have the skills to help us make a difference, then we’d love to hear from you.
The purpose of the role:
We have an exciting opportunity to be part of the next generation of product development at Endomag. You will join a team who are developing a new product, managing the project to transfer to the subcontract manufacturer over the next 12 month. You will undertake design reviews, complete all necessary systems engineering activities and related processes.
Your role will include the reviewing of requirements, the completion of verification and validation activities and documentation. You will also contribute to other projects and coordinate with the other members of the R&D team and wider groups at Endomag.
Our cutting-edge medical device products are developed and manufactured in collaboration with a network of third-party suppliers, contract development organisations, and consultants who work alongside Endomag’s R&D team.
Endomag is certified to ISO 13485 and product development activities will need to be operated and documented to relevant medical device standards.
Key responsibilities and duties:
- Manage and support the engineering design and development of new medical device products at various stages of development;
- Generate concepts and detailed design considering design for manufacturing; design for high reliability based on engineering analysis; design of experiments;
- Develop and document design requirements; lead design reviews and compile Design History and Technical Files that comply with Endomag’s ISO13485 Quality Management System;
- Manage risks and document risk management according to ISO14971 using techniques such as Hazards identification, risk analysis and evaluation, and design and process FMEA;
- Develop and execute verification and validation test procedures, and test reports;
- Work in a team environment; peer review work;
- Engineering, science or related subject degree or similar discipline
- 3-5 years in medical device development.
- Experience in aspects of engineering analysis and detail design; and formal testing as a part of new product development.
- Proven Solidworks experience.
- Knowledge of injection moulding manufacturing design ideally with experience of its transfer into manufacturing.
- Experience in writing technical documentation as a part of regulatory submissions such as Technical File or DHF.
- Experience in the management of external design consultants, suppliers and subcontractors.
- Understanding of global medical device regulations, requirements, and standards.
- Proven project management, organisational and time management skills.
- Excellent written and presentation skills communicating technical requirements, issues and solutions.
- Well-organised with the ability to work with critical attention to detail and high levels of accuracy.
- Willingness to occasionally travel within the UK and Internationally. We anticipate this will be an average of once per quarter.
Requirements
Experience and Knowledge
- Engineering, science or related subject degree or similar discipline
- 3-5 years in medical device development.
- Experience in aspects of engineering analysis and detail design; and formal testing as a part of new product development.
- Proven Solidworks experience.
- Knowledge of injection moulding manufacturing design ideally with experience of its transfer into manufacturing.
- Experience in writing technical documentation as a part of regulatory submissions such as Technical File or DHF.
- Experience in the management of external design consultants, suppliers and subcontractors.
- Understanding of global medical device regulations, requirements, and standards.
- Proven project management, organisational and time management skills.
- Excellent written and presentation skills communicating technical requirements, issues and solutions.
- Well-organised with the ability to work with critical attention to detail and high levels of accuracy.
- Willingness to occasionally travel within the UK and Internationally. We anticipate this will be an average of once per quarter.
Benefits
Pension: Non-contributory pension scheme, Endomagnetics contribute 9% of base salary, the employee contribution is discretionary.
Private Medical Insurance: For you and family.
Dental insurance: For you and your family.
Employee Assistance Programme: For you and your family (includes access to a virtual GP)
Discretionary Annual Bonus Scheme: payments up to 10% of salary.
Life Assurance: Death in service benefit (4x base salary).
Additional Health: Company eye tests and flu vaccinations.
Holiday: 25 days annual leave.
Your birthday Off: 1 day of paid leave per year for your birthday.
Annual Leave Buy Scheme: purchase up to 5 five days leave, in addition to your usual annual leave allowance.
Volunteering Leave: 2 days of paid leave per year for you to volunteer for a charity.
Paid Time Off for Dependents: 2 days of paid leave per year to deal with an emergency relating to your dependents.
Paid Time Off for a Domestic Emergency: 2 days of paid leave per year if you need to deal with a domestic emergency.
Maternity and Paternity: Enhanced maternity and paternity leave package.
Group Income Protection: Up to 75% of salary for periods of long-term sickness absence.
Environment: Pleasant working environment including a wellness room, spacious break out and lunch area with quality coffee and fresh fruit.
Facilities and Access: Vehicle and cycle parking. Positioned within easy walking distance to Cambridge North Rail Station.