About the role
We are a fast growing medtech startup backed by leading investors and innovation programs, developing a fully implantable Class III medical device targeting a significant unmet clinical need in chronic disease management. Our device uses a novel actuation mechanism to dynamically modulate a physiological parameter only when clinically required, with the goal of reducing patient complications, repeat procedures, and burden on healthcare systems.
We are advancing our device through design controls toward preclinical verification and First in Human studies, and are expanding our team with an experienced design engineer who brings deep expertise in end to end development of Class IIb or Class III implantable medical devices.
Job summary
As Senior Design Engineer, you will take a leading role in the development, optimization, and industrialization of our implantable device, from refinement of the current concept through all phases of the product development lifecycle and into industrialization and regulatory filing.
You will
Lead mechanical design tasks of a Class III implantable device from concept through production scale up.
Provide guidance and mentorship to team members, promoting best practices in medical device design and ensuring adherence to relevant medical device regulations.
Define and document product requirements, models, drawings, and specifications using CAD and related tools.
Conduct feasibility studies, design of experiments, prototypes, and simulations to establish robust specifications.
Plan and execute verification and validation activities, including test method validation, protocols, risk management, and documentation.
Ensure compliance with all relevant regulatory standards including MDR, 21 CFR 820, and ISO 13485, as well as applicable quality management systems.
Support manufacturing and relevant suppliers in process validation and design transfer activities.
Contribute to cross functional design reviews, risk management, FMEAs, and root cause investigations as required.
You bring
BSc or MSc in Mechanical Engineering, Biomedical Engineering, or a related field.
5+ years of end to end product design and development experience with Class IIb minimum and ideally Class III cardiovascular implantable devices.
Proficiency in materials science, including experience with metals and polymers commonly used in implantable and delivery devices.
Proficiency in 3D CAD software such as SolidWorks, Fusion 360, or similar, as well as design, simulation, and statistical analysis tools.
Experience in developing and conducting design verification testing for the long term viability of implantable devices, and working with external suppliers and vendors on outsourced activities.
Familiarity with medical device regulations and standards including MDR, ISO 13485, ISO 14971, ISO 10993, and FDA 21 CFR 820 quality management system and design control requirements.
Experience writing and delivering reports and technical summaries for clinical submissions and regulatory agencies.
Strong analytical, communication, and teamwork skills with accountability to deliver in a cross functional team environment.
Comfort working in a small, fast moving startup environment.
Fluency in English, both written and spoken.
What we offer
Competitive compensation aligned with responsibilities, including the possibility to share in our success.
Flexibility and trust: we focus on outcomes, not hours, and hybrid working is part of how we operate.
Meaningful work: everything we do is aimed at improving patient outcomes and quality of life.
A learning culture: we give and receive feedback directly and respectfully, and support each other to grow.
Ownership and responsibility: you will have real impact on the product and the company from day one.
An exciting atmosphere: thrive in a high energy, fast paced startup environment where every day brings new challenges and opportunities.
How to apply
Interested? Please send your CV in the application form below.
Application deadline: ASAP