Medical device engineer

Akkodis; Eigenbrakel; On-site; EUR 60,000 - 90,000; Full time

Job summary

Akkodis is seeking a Medical Device Engineer to support development, industrialization, and lifecycle management of drug delivery devices used with pharmaceutical products. You will collaborate with engineering, quality, regulatory, manufacturing, and external partners to ensure devices are developed, validated, and maintained per industry standards.

This role emphasizes cross-functional teamwork and regulatory readiness.

Qualifications

• 3+ years of experience in pharma/biotech/medical devices or combination products.
• Experience in a GMP-regulated environment and quality systems.
• Knowledge of ISO 13485, ISO 14971, MDR, 21 CFR 820/210/211, and ICH Q9.

Responsibilities

• Support design, development, and industrialization of medical devices and drug delivery systems.
• Contribute to NPI projects and lifecycle management activities.
• Coordinate technical activities with internal teams and external suppliers.
• Support design verification, design validation, and regulatory submissions.
• Maintain Design History Files and ensure regulatory compliance.
• Lead risk management, CAPA, and continuous improvement initiatives.
• Collaborate cross-functionally to meet project objectives and timelines.

Education

Biomedical/Mechanical Engineering degree

Life Sciences/Pharmaceutical Engineering background

Job description

Akkodis, is a global leader in the engineering and R&D market that is leveraging the power of connected data to accelerate innovation and digital transformation. With a shared passion for technology and talent, 50,000 engineers and digital experts deliver deep cross-sector expertise in 30 countries across North America, EMEA and APAC. Akkodis offers broad industry experience, and strong know-how in key technology sectors such as mobility, software & technology services, robotics, testing, simulations, data security, AI & data analytics. The combined IT and engineering expertise brings a unique end-to-end solution offering, with four service lines - Consulting, Solutions, Talents and Academy - to support clients in rethinking their product development and business processes, improve productivity, minimize time to market and shape a smarter and more sustainable tomorrow.

Akkodis is part of the Adecco Group. Our Webstite : www.akkodis.com

About the Role

We are currently looking for a Medical Device Engineer to support the development, industrialization, and lifecycle management of drug delivery devices used in combination with pharmaceutical products. As part of the Devices, Artwork & Packaging organization, you will work closely with engineering, quality, regulatory, manufacturing, and external partners to ensure medical devices are developed, validated, and maintained according to industry regulations and quality standards. The role combines technical expertise, project management, and cross-functional collaboration to bring new devices to market while supporting existing commercial products throughout their lifecycle.

The Responsibilities

• Support the design, development, and industrialization of medical devices and drug delivery systems.
• Contribute to New Product Introduction (NPI) projects and lifecycle management activities.
• Coordinate technical activities with internal teams and external suppliers.
• Support design verification, design validation, process validation, and regulatory submissions.
• Maintain technical documentation, including Design History Files (DHF).
• Ensure compliance with applicable medical device regulations, Quality Management Systems, and GMP requirements.
• Manage product changes, technical investigations, and continuous improvement initiatives.
• Support post-market activities, market feedback assessments, and product maintenance projects.
• Participate in risk management activities and contribute to corrective and preventive actions.
• Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, Packaging, and Development teams to deliver project objectives successfully.

The Requirements

• Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, Pharmaceutical Engineering, or a related discipline.
• Minimum 3 years of experience in the pharmaceutical, biotechnology, medical device, or combination product industry.
• Experience working in a GMP-regulated environment.
• Knowledge of medical device regulations and standards such as ISO 13485, ISO 14971, MDR, 21 CFR Part 820, 21 CFR Part 210/211, and ICH Q9.
• Understanding of medical device development, product lifecycle management, and risk management principles.
• Experience with Design Verification, Design Validation, Change Control, CAPA, and technical documentation is a strong asset.
• Strong project management and organizational skills.
• Excellent communication and stakeholder management abilities.
• Ability to work effectively within cross-functional and international teams.
• Proactive mindset with strong problem-solving and decision-making capabilities.

What do we offer?

At Akkodis, we support you in building your expertise and developing your career through:

• Mobility options and flexible benefits, depending on your package and eligibility.
• Training and development opportunities to strengthen your technical and professional skills.
• Onboarding and ongoing support, with regular opportunities to discuss your development.
• A network of experts and technical communities to share knowledge and learn from others.
• Career opportunities across projects, technologies and areas of expertise.
• Referral and business incentive schemes, subject to applicable conditions.