Requistion ID : 79834

Wellspect Healthcare is a leading global provider of innovative medical devices that help people suffering from urinary retention or chronic constipation. More than 1 000 employees around the world are dedicated to making a difference to people who need our products and services. Wellspect is one of the worlds’ leading manufacturers of intermittent urinary catheters, with LoFric® as the most known brand. As a help to those with chronic or severe constipation Wellspect has developed what likely is the world’s most advanced irrigation system, Navina™, combining a high degree of user convenience, clinical effectiveness and connectivity into one smart system. Wellspect strives to become climate neutral and leave the smallest possible environmental footprint. The company, with headquarters in Mölndal, Sweden, is present in more than 30 countries, and part of Dentsply Sirona, the worlds´ largest manufacturer of professional dental technologies. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Visit www.wellspect.com and www.dentsplysirona.com for more information.

Technical Product Manager

Join us as Technical Product Manager (TPM) and become part of a company where you can make a real difference in the quality of life for the people in need off our products and services.

This is a great chance to join our R&D team in a varied role facing many cross functional contacts and getting involved in problem solving and technology in the fore front.

We challenge and explore new ways in our effort to continuously improve ourselves, both individually and as a team. This is a great opportunity if you want to work in a successful company with products that make a real difference.

As one of our TPMs you will be in charge of the technical documentation of our medical device system products throughout their entire life cycle. You will be responsible for maintaining and improving medical device system products on the market today. In this role you will have cooperation within the full value chain from R&D and Operations to Commercial.

Wellspect has a strong team spirit and passion, we share knowledge, we care for each other, and we enjoy a good laugh. If you get energy from working close to products and technology and have an interest in regulations, then don’t miss this opportunity.

Responsibilities:

• Lead and coordinate changes in design, materials or functionality for existing medical device systems.

• Develop product documentation in compliance with regulatory requirements, Medical Device Regulation, FDA and internal Quality Management Systems.

• Development activities in various cross-functional projects to improve quality, reduce cost and expand to new markets.

We think you are a positive, structured, and driven team player that is motivated by problem solving. You are open for challenges and enjoy working together with highly skilled and committed colleagues.

Background / Qualifications.

• Academic background in engineering (bachelor’s or master’s degree).

• Several years of experience in product development or maintenance of medical devices.

• Several years of experience in developing and handling technical documentation.

• Very good documentation and communication skills, in both English and Swedish are expected.

• Experience in working with systems is an advantage.

• Experience with ISO 13485, ISO 14971, MDR(EU) 2017/745 and FDA Quality System Regulation is an advantage.

Note that we will review applications continuously, so be sure to send in your application as soon as possible.

We look forward hearing from you!