Senior Biocompatibility Scientist – MedTech R&D

Aerogen Ltd.; Galway; Hybrid; EUR 85,000 - 110,000; Full time

Benefits offered by this job

Excellent medical care

Bonus & Pension

Aerogen Connect

Job summary

Aerogen Ltd., Ireland’s leading medical technology company, seeks a Senior Biocompatibility Scientist to define and execute biocompatibility strategies across product life cycles, ensuring regulatory compliance and robust test strategies. You’ll collaborate with internal teams and external partners to manage testing and risk assessments.

The role emphasizes leadership in risk-based testing, regulatory interactions, and maintaining documentation per ISO/FDA/MDR standards, with opportunities to

Qualifications

• Minimum Level 8 Degree in Science/Technology/Engineering.
• Masters preferred with emphasis on materials.
• 7 years’ experience in quality engineering/materials/microbiology in Medical Devices.
• Experience with ISO, FDA, MDR, USP, AAMI, ANSI, ASTM and ISO quality requirements.

Responsibilities

• Serve as Subject Matter Expert for biocompatibility and microbiology across product development, manufacturing and supplier processes.
• Advise on material selection and testing strategies to ensure device safety and efficacy.
• Interpret and apply ISO, FDA, MDR, and AAMI standards to biocompatibility and microbiology processes.
• Maintain compliance with internal and external quality documentation and records.
• Coordinate with external labs and contract testing services to ensure high testing standards.
• Establish and monitor vendor relationships and performance.
• Perform due diligence in selecting accredited test labs for strategy and testing.
• Lead cross-functional project teams in planning, execution and validation of testing.
• Define biocompatibility and microbiology testing & validation requirements for projects.

Skills

Biocompatibility knowledge

Regulatory standards

Microbiology testing

Analytical techniques

Quality systems

Education

Level 8 Degree in Science/Technology/Engineering

Masters in Science/Technology/Engineering preferred (emphasis on materials)

Tools

MS Office

Job description

Aerogen Ltd., Ireland’s leading medical technology company, seeks a Senior Biocompatibility Scientist to define and execute biocompatibility strategies across product life cycles, ensuring regulatory compliance and robust test strategies. You’ll collaborate with internal teams and external partners to manage testing and risk assessments.

The role emphasizes leadership in risk-based testing, regulatory interactions, and maintaining documentation per ISO/FDA/MDR standards, with opportunities to