Senior Testing Engineer

SHL Medical; Stockholms kommun; Hybrid; SEK 700,000 - 900,000; Full time

Benefits offered by this job

Hybrid work policy

Professional development

Global organization

Modern Stockholm office

Job summary

SHL Medical is seeking a Senior Test Engineer to ensure robustness and compliance of medical device designs through rigorous testing. You will design assessment protocols, analyze data, and produce test reports for the design history file.

You will collaborate with cross‑functional teams, apply statistical problem‑solving techniques, and help develop innovative testing methods to improve device reliability and manufacturability.

Qualifications

• 5+ years of experience writing verification test plans and protocols, and completing test reports.
• Knowledge of medical device/regulatory standards (21 CFR Part 820, ISO 13485, ISO 11608, ISO 14971).
• Master's degree in Mechanical-, Material-, or Biomedical Engineering or similar.
• Fluency in English.

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 for design assessment, verification and high-volume production, including test design and fixture development.
• Write and execute design assessment and engineering test protocols; analyze data and author test reports.

Skills

Test planning

Verification testing

Design of experiments

Root cause analysis

Statistical methods

Test reporting

Cross-functional collaboration

Education

Master's degree in Mechanical, Material, or Biomedical Engineering

Job description

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.

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. 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 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 test products and develop fixtures.
• Collaborate with the development team to clarify design inputs and enhance testability.
• Apply statistical methods and problem-solving techniques (e.g., fishbone diagrams, 5 Whys, DMAIC) in investigations and experimental work.
• Support the development of innovative methods and models to assess device robustness.
• Take on additional responsibilities as needed to contribute to team objectives

Minimum Requirements

• 5+ years of experience writing verification test plans and protocols, and completing test reports
• 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
• Master's degree in Mechanical-, Material-, and, Biomedical Engineering or similar
• Fluency in English

Preferred Requirements

• Previous experience working with injection molded plastics
• Previous experience in the design and development of medical diagnostic or drug delivery equipment is preferred
• Good understanding of testing and analytical methodologies
• Previous experience in root cause analysis investigations or similar
• Previous experience in project leadership

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.

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

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