Hospitals

Odne AG

1-10

Switzerland

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, light-activated filler, thus helping people to 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 dedicated contract manufacturers. You will be taking over these production projects from the R&D team at different points in the design transfer process and ensuring a clean hand-over to the contract manufacturers. During pre-production and 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

*    Plan and lead design transfer and manufacturing projects in concert with the respective manufacturers and suppliers to meet our production demand
*    Actively engage with Odne’s R&D team and product managers to understand the products, their specifications and acceptance criteria
*    Support contract manufacturers in establishing the Device Master Record (drawings, assembly instructions, QC procedures, etc.)
*    Hold regular exchanges with key suppliers to monitor production progress and in-process issues–both remote and by visiting on-site
*    Maintain our supplier documentation in good order, following the SOPs of our ISO 13485-compliant quality management systems
*    Support your colleagues from R&D in evaluating and qualifying new suppliers

## Requirements

*    You are well-trained in a relevant engineering domain (BSc. or MSc., e.g. mechanical, electrical, life sciences)
*    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 challenges that have no clear solution
*    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.

## Benefits

*   A work that matters and can help improve people’s life.
*   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 company’s success through an attractive Employee Stock Ownership Plan (ESOP).
*   Flexible working hours, including the possibility of home office. 25 days of holidays.
*   Well-located 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.

Employee

Professional / Experienced

<p>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, light-activated filler, thus helping people to keep their natural teeth longer. </p>
<p><strong>Job description</strong></p>
<p>We are looking for a conscientious and proactive <strong>Manufacturing / NPI (new product introduction) Engineer</strong> with previous experience in medical device manufacturing to handle the production of our three products together with our dedicated contract manufacturers. You will be taking over these production projects from the R&amp;D team at different points in the design transfer process and ensuring a clean hand-over to the contract manufacturers. During pre-production and 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.</p>
<h2 id="tasks">Tasks</h2>
<ul>
<li>Plan and lead design transfer and manufacturing projects in concert with the respective manufacturers and suppliers to meet our production demand</li>
<li>Actively engage with Odne’s R&amp;D team and product managers to understand the products, their specifications and acceptance criteria</li>
<li>Support contract manufacturers in establishing the Device Master Record (drawings, assembly instructions, QC procedures, etc.)</li>
<li>Hold regular exchanges with key suppliers to monitor production progress and in-process issues–both remote and by visiting on-site</li>
<li>Maintain our supplier documentation in good order, following the SOPs of our ISO 13485-compliant quality management systems</li>
<li>Support your colleagues from R&amp;D in evaluating and qualifying new suppliers</li>
</ul>
<h2 id="requirements">Requirements</h2>
<ul>
<li>You are well-trained in a relevant engineering domain (BSc. or MSc., e.g. mechanical, electrical, life sciences)</li>
<li>You have a broad knowledge of manufacturing and prototyping processes (milling, turning, additive manufacturing, welding, joining, injection molding, silicone casting, mixing of chemical compounds, …)</li>
<li>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&amp;R, …)</li>
<li>You are used to solving problems with no clear solutions within a supporting team structure</li>
<li>You communicate openly and clearly with your team and your external collaborators and are aware of your own limits of understanding</li>
<li>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</li>
<li>You integrate easily into a matrix-like structure and function well in a team, but you can also set and follow your own goals</li>
<li>You can process and summarize complex situations concisely, allowing the relevant stakeholders to take quick decisions</li>
<li>You communicate at a professional level in English and ideally either German or French.</li>
</ul>
<h2 id="benefits">Benefits</h2>
<ul>
<li>A work that matters and can help improve people’s life.</li>
<li>An opportunity to shape a growing MedTech startup and support the first market launch and growth phase.</li>
<li>A startup environment, giving you high responsibility and room for personal development and learning.</li>
<li>A young, entrepreneurial, international, and enthusiastic team of 10 people with a common goal.</li>
<li>Participation in the company’s success through an attractive Employee Stock Ownership Plan (ESOP).</li>
<li>Flexible working hours, including the possibility of home office. 25 days of holidays.</li>
<li>Well-located office close to Stettbach station.</li>
</ul>
<p>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. </p>
<p>We guarantee an efficient &amp; 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.</p>


Manufacturing / NPI Engineer for MedTech Startup

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