Lead Engineer, Post Market Engineering

Overview:

Join Cook Medical as a Lead Engineer in our Post Market Engineering department. In this senior\-level role, you will serve as a key technical resource across all Post Market Engineering functions — driving design changes, leading optimization initiatives, and ensuring our marketed products continue to meet the highest standards of quality and regulatory compliance. The Lead Engineer works independently with limited oversight and manages complex/difficult technical projects or processes that have a major impact on departmental results.

The position will be based at William Cook Europe in Bjæverskov in Denmark.
Responsibilities:

• Lead and influence discussions within the team/department and with other functional personnel as necessary to progress projects/tasks.


• Efficiently manage multiple projects, timelines and resources


• Communicate progress and present to stakeholders/leadership


• Implement design changes to marketed products and lead optimization and cost reduction initiatives


• Manage change control processes and ensure compliance with ISO 13485, FDA regulations, and European Medical Device Regulations


• Maintain and update technical files for all marketed products


• Lead problem\-solving activities related to post\-market feedback. Identify and escalate problems to the appropriate level of management and implement possible solutions as necessary. Works with other team members to provide problem\-solving guidance.


• Maintain current knowledge of relevant technical standards and regulatory requirements


• Collaborate across functions to support continuous improvement and product quality

Qualifications:
What You Bring* \+7 years of engineering experience in a regulated industry (medical preferred)

• Engineering degree, preferably in Biomedical or Medical Engineering


• Experience in project management within a regulated industry


• Work experience within Risk Management


• Advanced proficiency in MS Word and Excel; basic competency in MS Access, Visio, MS Project, jBASE, Creo, and PLM systems


• Fluency in both Danish and English (spoken and written)


• Strong understanding of ISO 13485, FDA regulations, and European Medical Device Regulations


• Strong collaboration and independent leadership skills

You are an experienced engineer with strong analytical and investigative skills who thrives in a documentation\-intensive environment. You are a natural problem\-solver with excellent communication abilities and the confidence to work independently with initiative. You bring senior\-level competencies including the ability to develop processes and lead cross\-functional collaboration in a fast\-paced, ever\-changing environment. You take ownership of your work and are committed to delivering high\-quality outcomes that support patient safety and product excellence. Cook as a workplace

Cook Medical is a family owned, American company with well over 10\.000 employees worldwide
We invent, manufacture and deliver unique medical devices to the health care systems of the world. Serving patients is a privilege and we demand the highest standards of quality, ethics, and service in all that we do.
In Denmark, we are approximately 700 colleagues based in Bjæverskov and Ringsted, respectively.

At Cook Medical, we are proud of our special ”Cook spirit”. All over the organization, you are met with courtesy and pride of the quality of the work we carry out and the devices we develop. As a Cook employee, you contribute to the development of innovative, unique medical devices – and we are aware that we make a difference to patients all over the world every day. We appreciate qualities such as decisiveness, loyalty, and humor and work for an open dialog.

As a new Cook colleague, you are offered a well\-organized internal training course enabling you to quickly gain a thorough knowledge of the company. Apart from a salary package comprising bonus and pension schemes, we offer a high degree of flexibility in the planning of your daily work with the assignments in focus, equipment for teleworking, a good canteen when you are onsite, health assurance, and activities such as an Arts’ Society, a Sports’ Society and free use of the company’s own fitness center. Interested?

If you recognize yourself in this role, please send your application and summary at the earliest convenience and by 18th June 2026 at the latest. Interviews will be held continuously, and the start date is at the earliest convenience.
Please feel free to contact Manager, Product Sustaining in Post Market Engineering Jesper Bønnelycke Jensen by phone at 41954297 or by email at Jesper.jensen@cookmedical.com if you have any questions related to the job.

For further information, please visit www.cookmedical.com We look forward to hearing from you!

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