Manufacturing NPI Engineer for MedTech Startup

About Odne

Odne (formerly Lumendo) founded in 2018 is on a mission to revolutionize endodontic treatments in the US and EU. Our advanced cleaning technology and light-activated filler help patients keep their natural teeth longer.

Job description

We are looking for a conscientious and proactive Manufacturing / NPI (New Product Introduction) Engineer with previous experience in medical device manufacturing to handle the production of our three products together with our trusted contract manufacturers. You will be monitoring ongoing manufacturing activities and leading continuous improvement and cost reduction parallel you will conduct the design transfer to our contract manufacturers for two new projects currently under development. From early-stage to full-scale production you will be our point person to maintain close communication with the contract manufacturers and to collaborate in resolving any manufacturing or supply issues.

Tasks

• Manage ongoing manufacturing projects in concert with the respective contract manufacturers and suppliers to meet our production demand
• Engage hands-on with key suppliers to improve production processes resolve arising issues and reduce process costs - both remote and by visiting on-site
• Work together with Odnes R&D team and product managers to define the product specifications testing and acceptance criteria
• Transfer and develop new production processes hands-on and in close collaboration with our contract manufacturers.
• Support contract manufacturers in establishing the Device Master Record (drawings assembly instructions process validation QC procedures etc.)
• Maintain our supplier documentation in good order by evaluating and qualifying new and existing suppliers and following the SOPs of our ISO 13485-compliant quality management systems

Requirements

• You are well-trained in a relevant engineering domain (BSc. or MSc. e.g. mechanical electrical microengineering life sciences)
• You have at least 3 years of experience in medical device manufacturing ideally in a startup or CM environment
• 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 understand state-of-the art process development and quality control along with the underlying statistical methodologies (e.g. process/method validation six-sigma gauge R&R )
• 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 challenging tasks
• You integrate easily into a matrix-like 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 decisions
• You communicate at a professional level in English and ideally either German or French.
• You are willing to travel (mostly within Europe) up to 40% to allow for meaningful on-site interactions

Benefits

• Work that truly mattershelp improve peoples lives.
• A chance to shape a growing MedTech startup and support our growth phase
• A startup environment with high responsibility personal growth and learning opportunities.
• 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 hours home office options and 25 days of paid vacation
• Office near Zurich Stettbach train station

To apply please submit your resume and a brief cover letter describing your motivation for joining Odne and highlighting how your experience aligns with our requirements. We are committed to an efficient fair hiring process and look forward to reviewing your application.

We guarantee a fair and efficient hiring process. For legal reasons we can only consider candidates of CH or EU nationality or with a valid Swiss work permit.