Senior Process Dev Engineer, Med Devices - Data-Driven

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

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.