Design Control Specialist /Quality Engineer

LiNA Medical ApS; Poznań; On-site; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Private medical care

Sports card

MyBenefit cafeteria system

Flexible working time

Home Office

Co-financing for English language

Fruit and snacks

Job summary

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+.

Responsibilities

• 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.

Skills

Design Controls

Quality Engineering

Manufacturing Engineering

Process Engineering

Product Development

Sustaining Engineering

Education

Engineering degree

Tools

Minitab

Job description

About the Role

The Design Control Specialist/Quality Engineer plays a key role within the R&D and Manufacturing team by supporting both new product development and sustaining engineering activities throughout the medical device lifecycle. The role combines design control responsibilities with broader quality engineering activities, ensuring products continue to meet regulatory, quality and manufacturing requirements before and after market release.

The successful candidate will work closely with R&D, Production, Quality Assurance, Regulatory Affairs and Supply Chain to support design changes, supplier changes, process improvements, product investigations and verification activities while ensuring compliance with international medical device regulations and standards.

Your responsibilities

• Leading and supporting design control activities including design planning, design inputs and outputs, risk management, usability engineering, design verification, validation and design transfer.
• Supporting sustaining engineering activities for released products including design changes, engineering change orders and technical assessments.
• Supporting manufacturing and production by participating in process improvements, process validation activities and continuous improvement initiatives.
• Supporting supplier qualification activities including component changes, mould transfers, alternate suppliers and material changes.
• Planning, executing and documenting verification testing for product and process changes.
• Supporting statistical analysis of product and process performance including Statistical Process Control (SPC), trend analysis and capability assessments.
• Participating in investigations involving product nonconformances, complaints, CAPAs and manufacturing issues using structured root cause analysis methodologies.
• Working with cross-functional teams to identify and implement corrective and preventive actions.
• Preparing and maintaining technical documentation including design history documentation, protocols, reports, engineering assessments and risk management files.
• Supporting implementation of applicable international standards including ISO 13485, ISO 14971, IEC 62366-1 and MDR (EU) 2017/745.
• Supporting internal and external audits, including Notified Body inspections.
• Collaborating with suppliers, manufacturing partners and external laboratories during development and sustaining activities.
• Supporting continuous improvement of Design Control and Quality Management System processes.

Our requirements

• We are looking for candidates with experience in one or more of the following areas: Medical Device Design Control ,Quality Engineering, Manufacturing Engineering , Process Engineering, Product Development , Sustaining Engineering
• Bachelor’s or Master’s degree in Engineering, Biomedical Engineering, Mechanical Engineering, or related scientific discipline.
• Approximately 3-5 years of experience in medical device development, quality engineering or manufacturing engineering.
• Good understanding of Quality Management Systems and medical device regulations.
• Experience working with ISO 13485 and MDR 2017/745.
• Experience performing engineering investigations and root cause analysis.
• Experience planning or executing verification testing.
• Understanding of statistical techniques such as SPC, process capability or data trending would be considered an advantage.
• Experience working with suppliers or manufacturing processes would be advantageous.
• Strong analytical and problem-solving skills.
• Excellent communication and technical writing skills.
• English language proficiency (minimum B2).

Optional

• Experience within the following areas of competence is desirable:
• IEC 62366 Usability Engineering
• Process Validation
• Supplier Quality Engineering
• Six Sigma or Lean Manufacturing
• Minitab or statistical software

What we offer

• Opportunity to work across the complete medical device lifecycle.
• Involvement in both innovative new product development and sustaining engineering.
• Collaboration with international multidisciplinary teams.
• Professional development in quality engineering, design controls and manufacturing engineering.
• Full-time job contract;
• A number of benefits (private medical care, sports card, MyBenefit cafeteria system, flexible working time, Home Office, co-financing for English language classes, fruit and snacks);
• Great atmosphere in the office and interesting challenges;