Lead Test Engineer within MedTech

About the company

Founded as a spin-out from AstraZeneca in 2017, OnDosis is a Swedish start-up addressing one of the major opportunities in healthcare; personalized dosage of medicines. The proprietary technology platform is centered around a connected handheld dosing device that delivers tailored doses of oral medicines. By combining individual dosing of traditional drug-based medicines augmented by digital therapeutics, OnDosis opens a new chapter in personalized medicine where the mission is to improve patients’ life through delivering the perfect dosage; individualized, intuitive, and intelligent. OnDosis is based in the AstraZeneca BioVenturehub in Mölndal, Sweden.



The Role as a Lead Test Engineer

As Lead Test Engineer you will be a key member of a cross functional design core team for the development of a combination product (device + drug product). You will get the opportunity to develop the lab from an early stage and be an important part of OnDosis exciting journey to improve patients’ life. We are looking for a senior team member, who will lead and coordinate test and verification activities and programs, related to both analytical and mechanical testing. The test work will be conducted in close collaboration with internal and external team members and partners.

Key responsibilities

- Oversee and ensure development, testing and delivery of test data accompanied by relevant testing statistic input to projects to facilitate data-based decisions
- Drive scientific and performance excellence in defined areas
- Coordinate other test engineers
- Ensure effectiveness of resources and equipments while securing project milestones
- Ensure that applicable laboratory safety laws/standards are applied
- Establish and ensure lab processes and SOPs are in compliance to relevant standards and regulations
- Make suggestions for investments of equipment to the direct reporting manager
- Manage sourcing, installation and qualification of test equipment
- Plan and lead engineering test activities to support design and development work
- Ensure that tests and data are delivered on time to support business objectives
- Develop and validate test methods
- Coordinate test activities with external partners
- Communicate test results and conclusions to the management or the project team




Requirements and skills

- MSc. in Mechanical Engineering or Chemical Engineering
- 5-10 years of experience from medical device, pharmaceutical or other relevant industry
- 5+ years in testing and laboratory activities.
- Extensive experience in test and verification, including development and validation of test methods as well as sample sizing.
- Fluent in English


It is meritorious if you have experience from drug-device combination products and have been working with IEC60601-1 and ISO14971. It is also an advantage if you have good leadership and interpersonal skills. As a person, you are a good teamplayer and like to be in a fast-paced environment where you will have the possibility to develop yourself together with the company.

Location

The role will be located in Astra Zeneca's premises in Mölndal



How to apply

For more information about the role, please contact:

Ulrika Ydse, mobile 0761-67 10 51, ulrika.ydse@technogarden.se
Per Gottfridsson, mobile 0735-17 99 91, per.gottfridsson@technogarden.se

We work with a continuous selection and look forward to your application as soon as possible.