Senior Developement 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 Senior Development Engineer

As a Senior Development Engineer you will lead the mechanical design of combination products in our growing medtech company.

OnDosis revolutionizes the way we take medicines by combining technology with traditional pharmaceutical processes into personalized healthcare. We are looking for a senior team member who can take lead for the development and design of OnDosis' life changing products as well as problem solving of mechanical issues. You will coordinate a team of design engineers and external partners through the entire product development process - from concept generation to final commercial design.

You get stimulated by fast-paced environments where you are designing, evaluating the product and representing design development in a cross functional design core team. In the role you will identify and initiate investigations of medical device technologies, prototype and test solutions for device features, assessing risks and requirements related to these solutions.

Key responsibilites

- Lead and contribute to the development of Ondosis' products
- Be responsible for suggesting, assessing and implementing solutions throughout the product life cycle
- Encourage new ideas and solutions to overcome design challenges
- Design prototypes and perform engineering evaluations
- Select and evaluate materials and component technologies
- Ensure that design documents are in compliance with relevant Quality and Regulatory standards
- Contribute to verification and validation of products and production tools
- Participate in a cross functional design processes such as Risk Management and Human Factors, to develop effective designs
- Interact with Test Engineer to define and design mechanical tests and systems
- Collaborate with external design partners as well as external manufacturing partners


Requirements and skills

- Msc. in Mechanical Engineering
- 10+ years' experience of working with Design Control/development of medical devices
- Documented experience of process for development of Medical Devices; MDR, ISO 13485, FDA 21 CFR 820 and ISO14971
- Expertise in design for injection molding
- Structured, scientific and systematic thinking
- Excellent skills in Creo or Solidworks
- Good knowledge of reading and interpretation of tolerance analysis
- Good technical and documentation skills
- Fluent in English - oral and written


It is meritorious if you have experience of IEC60601-1 or/and have been working with combination products (device + drugs). Experience in systems integration of electronics products is welcomed.

As a person you have good interpersonal skills and have the ability to work in teams as well as individually. You are structured and ready to dig deeper into details if needed. To succeed in the role you need to show a hands-on passion and be able to communicate your ideas and concepts both verbal and visually. You have a desire to learn from new challenges and have the flexibility to respond quickly to changing context and work environment.



Location

The role will be located in AstraZeneca BioVentureHub in Mölndal

How to apply

For more information about the role, please contact:



Ulrika Ydse, mobile 0761-67 10 51, ulrika.ydse@technogarden.se or 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.