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Process Engineer

vor 2 Monaten


SaintSulpice, Schweiz Tandem Diabetes Care Switzerland Sàrl Vollzeit

GROW WITH US:

Tandem Diabetes Care Switzerland Sàrl, a subsidiary of Tandem Diabetes Care, Inc., is a MedTech start-up located in EPFL’s Innovation Park in Lausanne, Switzerland. Tandem Diabetes Care, Inc., is a global insulin delivery and diabetes technology company based in San Diego, California. Together we are creating new possibilities for people living with diabetes, their loved ones, and the healthcare providers through a positively different experience.

INNOVATE EVERYDAY:

Tandem Diabetes Care Switzerland is developing Sigi™, a next-generation insulin “patch pump” that will offer additional treatment options for people with diabetes. This pump is based on a patented microfluidics technology developed in-house over the past 6 years. You can find out more about Sigi here.

A DAY IN THE LIFE:

The Process Engineer will be involved in the different phases of the process design, industrialization, and manufacturing activities of the Sigi™ medical device. This role will be responsible for developing, configuring and optimizing industrial processes from proof of concepts up to manufacturing startup and certification. The Product Industrialization will be done in close collaboration with the Product Development Team. Flexibility and open-minded spirit are key to providing quality solutions in a cutting edge, multidisciplinary environment. The candidate must also be able to work independently and be keen to work himself on engineering tasks. A hands-on approach is required.

Working from Tandem Diabetes Care Switzerland’s office onsite in Switzerland, you’ll have to….

  • Define robust manufacturing processes for successful industrialization of products.
  • Carry out process development tasks.
  • Define process setups for manual and semi-automated manufacturing.
  • Develop manufacturing equipment specifications for suppliers.
  • Participate as a process support during the commissioning, start-up and performance testing phases (FAT/SAT/IQ/OQ/PQ).
  • Lead projects linked to process development and industrialization.
  • Create and deliver regular verbal and written project updates.
  • Create or organize the required documentation (design manufacturing records) as needed.
  • Manage third-party suppliers.
  • Ensure compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
  • Other responsibilities as assigned.

YOU'RE AWESOME AT:

  • Ability to work effectively in a fast-paced environment of constant change.
  • Detail oriented with demonstrated ability to proactively follow-up on areas of responsibility in a timely manner.
  • Structured technical mindset with great attention to detail, and prompt to document activities.
  • Ability to effectively use MS Office suite (Word, Excel, Outlook) and other applicable software packages.
  • CAD experience.
  • Experience working in an ISO 13485 environment with its IQ/OQ/PQ requirements.
  • Familiar with statistical analysis software.
  • Experience in plastic injection, assembly processes as laser welding, US welding, heat welding and gluing.
  • Solid experience in structured process engineering (requirements-driven engineering, DOE, PFMEA, formal verification, release processes, etc.).
  • Experience in new product introduction.
  • Project management skills and ability to work with external suppliers.
  • Positive attitude, willingness to continuously improve and help others.
  • Drive and commitment to go the extra mile and find a better way; a team player with the ability to work cross-functionally.
  • Strong at taking initiative, fast learner, enthusiastic, curious.
  • Fluency in French, excellent knowledge of English, German highly appreciated.

YOU'LL NEED:

  • Master’s degree in Mechanical, Material Engineering or equivalent combination of education and applicable job experience.
  • +5 years’ work experience in manufacturing/process engineering.
  • Project management experience.

BE YOU, WITH US

We are firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.

REFERRALS:

We love a good referral If you know someone that would be a great fit for this position, please share