Senior Hardware Testing Engineer

About the company

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

As a Senior Test Engineer, you will play a critical role in ensuring the robustness and compliance of medical device designs through rigorous assessments and innovative testing methods and related simulation models. You will collaborate with cross-functional teams, serve as a subject matter expert in test case design, and apply statistical problem-solving techniques to drive continuous improvement. This position offers the opportunity to contribute to the development of high-quality medical devices that meet stringent industry standards.

Main Responsibilities

• Ensure robust medical device designs through early and rigorous design assessments.
• Ensure compliance with engineering principles, company standards, customer requirements, and related specifications.
• Develop test methods and models for design assessment, verification and high-volume production, including test design and mechanical/dynamical fixture development.
• Write and execute design assessment and engineering test protocols; analyze data and author test reports for the design history file.
• Interact with internal stakeholders from various departments to develop test methods, test fixtures and test products to assess device robustness.
• Collaborate with the development team to clarify design inputs and enhance testability.
• Perform problem solving and root-cause-investigation, including collaboration with designers and simulation, applying statistical methods and problem-solving techniques (e.g., fishbone diagrams, 5 Whys, DMAIC) in investigations and experimental work.
• Take on additional responsibilities as needed to contribute to team objectives.

Minimum Requirements

• University degree in Mechanical-, Material-, Biomedical Engineering, combined with 3+ years of work experience
• In-depth knowledge of mechanical design and passion for testing technology
• Skilled in structured problem solving, analytical and logical thinking
• Familiar with 3D design software (SolidWorks or other CAD) and technical drawings
• Fluency in English

Preferred Requirements

• Good understanding of testing and analytical methodologies together with positive and curious attitude
• Previous experience in root cause analysis investigations or similar
• Previous experience in project leadership
• Previous experience in the medical device or pharma industry, ideally with working knowledge of regulations and standards such as 21 CFR Part 820, ISO 13485, ISO 11608, ISO 14971
• Previous experience working with injection molded plastics or medical device testing is a merit

We Offer

• A company culture Focusing on our Customers, Operating with Ethics and Integrity, Driving Simplicity, Learning, Improving & Delivering Together.
• Challenging assignments in a fast growing and innovative industry.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy.
• A modern working environment in Nacka Strand, Stockholm, with multicultural and motivated teams.

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents.

For more information on SHL Medical, please visit: shl-medical.com

Please note: We do not accept applications from recruitment agencies for this role.