Mechanical Engineer Medical Devices

Mechanical Engineer Medical Devices


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 and IoT solutions for feedback to patients, doctors and payers. 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 right dosage; individualized, intuitive, and intelligent.


The role as a Mechanical Engineer
As a Mechanical engineer, you are instrumental in the development of technical mechanical solutions related to plastic parts assembled in OnDosis medical devices, as well as being an important contributor in the overall development of the product.
You are actively contributing to the whole development chain from the design of mechanical parts to the design of innovative drug dispensing systems, mechanical requirements, validation and product release as well as actual experience of a product you have taken part in developing making a real impact on patients’ health.

Key responsibilities
· Be responsible for the technical delivery of specific projects within device development with regards to Mechanics (mechanical solutions integrated in the device) according to relevant standards and agreed with the project team.
· Deliver technical solutions like concepts, detailed designs and documentation on time to projects in accordance with OnDosis Quality Management System.
· Contribute to the integration of the mechanical components into a working system according to specification including drug product, electronics, fixtures, etc.
· Contribute to the delivery and update of mechanical requirements and risk analysis or FMEAs.
· Work closely with other mechanical engineers and with project team members (hardware lead, test lead, etc…) to deliver the project and solve issues particularly regarding interface aspects of the integration.
· Contribute to Mechanical Technical Reviews with the relevant documents.
· Responsible for ensuring that Geometry Assurance has been performed on the dimensions and tolerances of the mechanical parts
· Responsible for implementing Design For Manufacturing and Assembly
· Participate in Planning and Executing Verification products and prototypes
· Responsible for working according to and ensuring compliance with OnDosis ISO13485 Quality Management System


Requirements and skills
Mandatory:
Mechanical Engineer with a minimum 5 years of professional experience from Medical Device development.
A minimum of 5 years experience of the software CREO.
Experience from relevant regulations, international standards and guidelines, such as ISO 13485, ISO 14971, MDR, CFR Part 820, and excellent understanding of design control principles.
Experience in Risk analysis ISO14971
Experience from IEC60601-1 electrical medical equipment
Documentation skills and experience with working within a Quality Management System
Fluent in English


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´
Contact
Stéphane Baronnet, Head of Device Development, s.baronnet@ondosis.com, +46729873810