Senior / Staff Quality Engineer (m/f/d)

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

As a Senior / Staff Quality Engineer you will take the lead in ensuring the outstanding quality of our surgical products in Craniomaxillofacial and Neurosurgery. Serving as a central liaison for Regulatory Affairs, Quality Assurance, and Clinical departments, your role involves making critical decisions and ensuring compliance with legal and quality standards. Collaborate closely with diverse teams, including R&D and Marketing, to seamlessly integrate business needs into the product development process, reflecting our commitment to excellence.

What will you do

• As a Senior / Staff Quality Engineer you will be part of an international product development team specializing in titanium implant systems (supporting any other field of application - polymers, biomaterials, medical electrical devices and patient-specific solutions - is possible depending on the pipeline and team set-up).
• You will help define product requirements, ensure their implementation in robust designs, and plan and evaluate product verification and validation.
• You will moderate the creation of product risk analyses and ensure that necessary information is communicated at interfaces.
• The design of products undergoes scrutiny by various interdisciplinary teams - you will be involved, bringing in the quality perspective.
• The majority of technical documentation passes through your hands. You are the main reviewer for completeness, correctness, and plausibility.
• As a team, we are responsible for assessing health risks of incidents after product launch. You write Health Risk Assessments with information previously agreed upon in the failure investigation.

Etc.

What will you need

• You have completed BS in Engineering (Biomedical, Mechanical, Electronical, Software etc.) or related degree. Master is a nice to have.
• You have gained a minimum of 3 years' of professional experience in medical technology or another regulated sector (such as pharma or biotechnology).
• You possess extensive experience in Product Design Quality, Research and Development (R&D), or Regulatory Affairs (RA) within a regulated market.
• Ideally you have already acquired knowledge in one or more desirable qualifications such as: DHF, Design, Risk Management, Regulatory Clearance, Audit, Project Management, Design Control, Biocompatibility, Statistics, Usability Engineering, or Human Factors.
• Ideally you bring added value to our team with your experience in software (nice to have).

• Your English language skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office. German is a strong preference.

Additional information

Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence 1ce a week on site at our location in Freiburg should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.

Your application

We are looking forward to your online application including your CV (cover letter, transcript of results, and references are nice to have). Please note to upload all attachments directly in our application procedure under the item "CV".

Please note that the internal job title may differ from the ad title.

Your contact:

In case you have further questions regarding the position, please feel free to directly reach out to Monika Ambroziak: [email protected]

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.