Senior Test Engineer

As a Senior Test Engineer, you provide subject matter expertise in testing activities (test planning, statistical methods, data analysis) within different areas of product development at OnDosis and in collaboration with external partners. You ensure that verification and analytical tests are planned, performed, and analysed based on relevant statistical methods and comply with applicable quality procedures, guidelines, and standards. An important aspect of this role is to ensure that OnDosis develops and manufactures dosage managers that are consistent with the requirements for clinical safety and performance as well as the requirements and expectations of customers and end users.

Your responsibilities

• Development, maintenance, and continuous improvement of methods for testing and verification, including statistical methods for sample size calculation, in compliance with applicable guidelines and standards
• Driving and participating in the planning and execution of critical product development activities
• Verification planning within OnDosis’ development projects in collaboration with development partners
• Planning, coordinating, executing, and documenting analytical tests (with focus on dispensing performance) at OnDosis’ facilities and external laboratories as part of product development projects, technology development projects, life-cycle management activities, etc.
• Ensuring that test results are delivered and communicated on time and with quality within the organization as well as to external partners to support business objectives
• Planning and coordinating outsourcing and transferring analytical test methods to external partners as well as providing training and support

Who are we looking for?

We are looking for talented professionals with passion and drive. Dealing with many internal and external stakeholders, you are a team player with strong communication skills in English (both written and spoken). You have a strong attention to details and preferably a good understanding of complex projects involving medical devices and/or drug-device combination products through all phases of device development to commercialisation.

Essential for the role

• Experience from test planning and test analysis in medical devices and/or pharmaceutical industry, with focus on analytical, mechanical, and system testing or alternatively device- or drug-device combination product testing
• In-depth knowledge of statistical methods for sample size calculation and data analysis
• In-depth experience from working with statistical software
• Experience from developing test methods for verification testing as well as validation plans for test methods and fixtures.
• Experience from developing design of experiment plans and analysing the output data of those tests.
• Technical writing and documentation skills
• Team player with excellent analytical and coordination/planning abilities

Desirable

• Understanding of drug development principles relevant to solid drug formulations such as pellets, powders, tablets
• Good understanding of device design principles
• Experience from risk management

Why OnDosis?

You will have a great opportunity to join early in a growing company on the global arena with big and bold ambitions. Our clients are large multinational pharmaceutical companies. Your colleagues are all highly skilled professionals with in-depth industry knowledge. The commitment to establishing a new standard for the dosing and administration of medicines is present in everything we do. There is no doubt you will be part of an exciting journey on the global pharma- and medical devices arena where you will have the opportunity to make an impact.

Apply today!

This recruitment is managed by our recruitment partner, Moveup Consulting AB. To apply, please send your CV and a cover letter to Fredrick Asare; fredrick.asare@moveup.se

If you have questions regarding OnDosis or this open position, please contact

Fredrick at +46 (0)733 44 09 00

By submitting your application, you also consent to us storing your personal data, including CV & cover letter and that we have the right to share this information with third parties (our client). You can revoke the consent whenever you want.