Senior Research and Development Engineer, Process Development

Cook Medical Incorporated; Bjæverskov; Hybrid; DKK 700,000 - 900,000; Full time

Benefits offered by this job

Bonus and pension schemes

Teleworking equipment

Canteen on site

Health assurance

Arts and Sports clubs

Job summary

Cook Medical Incorporated in Denmark seeks a Senior Engineer, Process Development, to lead technical work on challenging manufacturing projects and ensure design history is solid and traceable. You will collaborate across teams to meet quality and regulatory standards and mentor junior engineers.

The role emphasizes process characterization and validation (IQ/OQ/PQ), DOE and SPC, and applying AI/data tools to make data-driven decisions, with occasional travel as needed.

Qualifications

• Bachelor’s degree in engineering (or higher) in medical devices or a regulated industry.
• 5+ years hands-on engineering experience in medical devices or a regulated industry.
• Experience in process characterization, IQ/OQ/PQ, DOE and SPC.
• Ability to work with AI and data tools and explain results clearly.

Responsibilities

• Lead the technical side of smaller projects or own a slice of larger ones, setting goals and timelines.
• Collaborate with engineers, physicians, and product managers to bring medical devices to life.
• Develop procedures and guidance, keep design history documentation solid and traceable.
• Mentor junior colleagues and share knowledge across teams, while ensuring quality and regulatory compliance.

Skills

Leadership

Process characterization

Process validation

DOE

SPC

Critical thinking

Technical writing

AI/Data tools

Regulatory understanding

Travel

Education

Engineering degree (Bachelors or higher)

Job description

Overview

As Senior Engineer, Process Development, you'll bring engineering know-how to some genuinely tricky manufacturing challenges, helping make sure our products and processes hold up to the clinical, safety, and quality standards our work demands.

You'll take the lead on smaller projects and own meaningful pieces of bigger ones, working closely with colleagues across departments. Over time, you'll deepen your own technical expertise and become someone others turn to for guidance – while helping shape the procedures and know-how that make the whole team better.

Responsibilities

Day to day, you'll lead the technical side of smaller projects or own your slice of larger ones – making the key process calls, learning from how past projects went, and following through on the goals set for your area. You'll also team up with project groups and leadership to figure out where your focus should be, dig into best practices, and turn what you learn into procedures or guidance that other teams can actually use.

You'll work alongside engineers, subject matter experts, physicians, and product managers to help bring new medical devices to life – using a good dose of creative problem-solving along the way. That means staying on top of project timelines and milestones and keeping the documentation in order so the design history behind every device is solid and traceable.

Beyond your immediate projects, you'll build good working relationships across teams, help keep things running within quality and regulatory guidelines, and contribute your technical perspective when new ideas or intellectual property are on the table. You guide and mentor junior colleagues and share what you know with the team.

Qualifications

You'll need a bachelor’s degree in engineering (or a master's or PhD), plus experience in a technical role within medical devices or another regulated industry. Leadership experience on projects is a plus, but what matters most is that you think critically, write clearly, and know how to get things done with people from different teams and backgrounds.

We're looking for at least 5+ years of hands-on experience in a similar engineering role within the medical device industry or another regulated industry. That should include solid, hands‑on experience in process characterization, process validation (IQ/OQ/PQ), and applying statistical tools such as DOE and Statistical Process Control to make robust, data‑driven process decisions.

You're also comfortable working with AI and data tools day to day – able to judge whether an AI output makes sense, spot when something's off or biased, and explain what you've found in plain terms to the people around you.

• Familiarity with ISO, EU, or FDA medical device standards is a plus.
• Some project management experience helps but isn't required.
• Occasional travel may come with the role.

Cook – a special workplace

Cook Medical is a family owned, American company with well over 12.000 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 800 colleagues based in Bjaeverskov 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.

Interested?

• 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
• activities such as an Arts' Society, a Sports' Society and free use of the company's own fitness center

For further information, please visit www.cookmedical.com