RD Engineer for MedTech Startup

Odne (formerly Lumendo) founded in 2018 and ISO 13485 certified aims to disrupt the endodontic device market in the US and EU. Our mission is to develop the most advanced solution for this very challenging dental procedure with disruptive cleaning technology and a novel lightactivated filler thus helping people to keep their natural teeth longer.

Job Description

We are looking for a broadminded and versatile R&D Engineer with previous experience in medical device development to support our engineering team. Our three main devices as well as their accessories make use of very diverse technologies and physical effects in clinical use. As we receive feedback from first customers you will be focused on updating the user needs and design input requirements. Based on this you will plan and implement new features in the existing product lineup both in smaller revisions and in developing a second generation of devices. For this you will design ingenious improvements and innovative fixes that are costeffective and easily tested in V&V and transferred to manufacturing. You will be involved in multiple subprojects with different levels of urgency to achieve the finetuning of our productmarket fit.

Tasks

• Development of new or improved features and products in Odnes current offering
• Drafting new User Needs and Design Input Requirements based on validated market feedback
• Definition of engineering subprojects encompassing the planning of activities and their timeline as well as estimating resource needs and costs
• Executing on engineering subprojects together with the R&D team: design new features parts and products carry out early iterative testing engage with suppliers to produce parts confirm design output in V&V testing
• Documenting the design and development process thereby maintaining our Design History Files in good order
• Support your colleagues from NPI and Supply Chain in transferring designs into production

Requirements

• You are welltrained in a relevant engineering domain (BSc. or MSc. e.g. mechanical electrical microengineering) and have at least 4 years of experience in medical device development
• Beyond your core domain you have a good working knowledge of other engineering areas such as software development fluid dynamics low power electronics or material science
• You have an innovative mind for solving problems but you can also adhere well to quality and regulatory constraints
• You have 4 years of experience in medical device development and an excellent understanding of the development process (according to ISO 13485) as well as the maturity of a design during each of its phases
• You can demonstrate having applied sound requirements engineering risk management and change management practices
• You carry out handson testing activities in early R&D as well as during V&V and handle the different degrees of documentation with ease
• You have a broad knowledge of manufacturing and prototyping processes (milling turning additive manufacturing welding joining injection molding silicone casting mixing of chemical compounds )
• You draft high quality engineering drawings/schematics related to your engineering domain
• You are used to solving problems with no clear solutions within a supporting team structure
• You communicate openly and clearly with your team and your external collaborators and are aware of your own limits of understanding
• You are open to interacting with many interesting people with varied backgrounds becoming acquainted with breakthrough technologies and accepting challenges that have no clear solution
• You integrate easily into a matrixlike structure and function well in a team but you can also set and follow your own goals
• You can process and summarize complex situations concisely allowing the relevant stakeholders to take quick decisionsYou communicate at a professional level in English and ideally either German or French

Benefits

• A work that matters and can help improve peoples lives.
• An opportunity to shape a growing MedTech startup and support the first market launch and growth phase.
• A startup environment giving you high responsibility and room for personal development and learning.
• A young entrepreneurial international and enthusiastic team of 10 people with a common goal.
• Participation in the companys success through an attractive Employee Stock Ownership Plan (ESOP).
• Flexible working hours including the possibility of home office. 25 days of holidays.
• Welllocated office close to Stettbach station.

We look forward to receiving your application. Please include a brief cover letter explaining your motivation to join our team and why you think your profile matches our requirements.

We guarantee an efficient & fair hiring process. Please note that for legal reasons we can only consider candidates of CH or EU nationality or candidates with a valid Swiss work permit.