Design Control Engineer — Medical Devices & Quality Impact

LiNA Medical ApS; Poznań; Hybride; PLN 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

Private medical care

Sports card

MyBenefit cafeteria system

Flexible working time

Home Office

Co-financing for English language

Fruit and snacks

Résumé du poste

LiNA Medical ApS is seeking a Design Control Specialist/Quality Engineer to support both new product development and sustaining engineering throughout the medical device lifecycle. You will collaborate with R&D, Production, QA, Regulatory, and Supply Chain to ensure compliance and continuous improvement across design changes, supplier changes, and process validation.

The role emphasizes risk management, verification/validation, and implementation of applicable standards, including ISO 13485 and

Qualifications

• Bachelor’s or Master’s degree in Engineering, Biomedical or Mechanical.
• 3–5 years in medical device development or quality/manufacturing engineering.
• Strong knowledge of QMS and medical device regulations.
• Experience with ISO 13485 and MDR 2017/745.
• Excellent analytical and writing skills; English B2+.

Responsabilités

• Lead and support design control activities including planning, inputs/outputs, risk management, usability, verification, validation, and transfer.
• Support sustaining engineering with design changes, ECOs, and technical assessments.
• Assist manufacturing through process improvements and validation activities.
• Support supplier qualification for component changes and alternate suppliers.
• Plan, execute, and document verification testing for changes.
• Analyze product and process performance using SPC and data trends.
• Participate in investigations of nonconformances, CAPAs and manufacturing issues.
• Collaborate with cross-functional teams to implement corrective actions.
• Prepare and maintain design history files and risk management documentation.

Connaissances

Design Controls

Quality Engineering

Manufacturing Engineering

Process Engineering

Product Development

Sustaining Engineering

Formation

Engineering degree

Outils

Minitab

Description du poste

LiNA Medical ApS is seeking a Design Control Specialist/Quality Engineer to support both new product development and sustaining engineering throughout the medical device lifecycle. You will collaborate with R&D, Production, QA, Regulatory, and Supply Chain to ensure compliance and continuous improvement across design changes, supplier changes, and process validation.

The role emphasizes risk management, verification/validation, and implementation of applicable standards, including ISO 13485 and