Medical Device Validation jobs

The Engineer (Level I) will perform precision braiding of implantable components within a cleanroom environment. The Engineer will ensure manufacturing excellence by operating advanced machinery, maintaining rigorous quality documentation, and supporting process validations. The Engineer will contribute to the development of new process and product introduction as delegated by the Management Team and will complete assigned work in a manner which complies with the standards and procedures to which the company adheres and in line with Customer requirements.

The associate in this role has the authority and responsibility to:

• Design experiments, analyze data, and optimize processes to meet performance and regulatory requirements
• Collaborate with a diverse team of scientists and engineers to ensure project alignment with the Customers/Legal Manufacturers regulatory and quality standards
• Comply with Quality, Regulatory and company policies and systems
• Communicate with cross-functional teams, senior management, and business unit leaders.
• Maintain comprehensive records, documentation, and reports to ensure regulatory compliance and intellectual property protection (where applicable).
• Take ownership of assigned projects, managing timelines, budgets, and resources effectively.
• Remain on the forefront of emerging industry practices
• Work closely with the Customer/Legal Manufacturer and/or Internal resources to execute high-precision braiding operations using Nitinol wire and polymer filaments, ensuring all products meet established engineering drawings and performance specifications.
• Contribute to process development, prototyping, and testing under minimal supervision
• Carry out process development, validation (IQ/OQ/PQ), and risk management activities (e.g. pFMEA)
• Develop prototypes which are consistent with the customers’ clinical and design requirements
• Develop test method designs and support execution of test method validation
• Stay abreast of emerging developments in Nitinol processing, braiding technologies, and evolving ISO/FDA regulatory standards to ensure the continuous improvement of manufacturing practices.

Qualifications

· Bachelor’s degree in a relevant Science or Engineering field (e.g. Biomedical, Mechanical or Materials etc.)

Skills

· Ability to set up, troubleshoot, and operate wire braiding machines (e.g., Steeger, Herzog).

· Foundational understanding of ISO 13485 and FDA QMSR.

· Proficiency with precision metrology tools (micrometers, vision systems, tensile testers).

· Competence in 3D CAD modelling software and drafting standards (geometric dimensioning and tolerancing).

· Ability to work effectively both independently and in a team environment.

· Ability to generate and maintain technical documentation & test reports.

· Strong attention to detail and organization skills.

· Excellent problem-solving and analytical abilities.

· Strong attention to detail and organization skills.

· Strong communication and interpersonal skills.

Experience

· Minimum of 2-3 years of experience in a similar role.

· Experience with wire braiding machines.

· Familiarity with Nitinol properties (shape memory/superelasticity) and processing of implantable-grade materials.

· Proven track record of successfully executing engineering projects.

· Experience in engineering design and project management.

· Risk management (e.g. pFMEA) creation and execution of mitigating actions.

· Experience with process evaluation, reviews, specifications, protocols and report writing and execution.

· Risk management (e.g. pFMEA) creation and execution of mitigating actions.

· Experience with verification & validation and transfer to manufacturing activities

Pay: €50,000.00-€55,000.00 per year

Benefits:

• Bike to work scheme
• Company pension
• Employee assistance program
• On-site parking
• Private medical insurance

Work Location: In person