Senior Mechanical Engineer

Planet Pharma; Diepenbeek; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Planet Pharma is recruiting a Senior Mechanical Engineer to lead mechanical engineering activities across the full product lifecycle of medical devices and drug-device combination products, from concept to commercialisation.

You will drive design, development, verification and validation, collaborate with R&D, Manufacturing, Quality, Regulatory Affairs, and external partners, and mentor junior engineers while ensuring compliance with design controls and regulatory requirements.

Qualifications

• Significant experience in mechanical engineering within the medical device or combination product industry.
• Experience with design controls and product development in regulated environments (Class IIb/III).
• Knowledge of manufacturing processes, industrialisation and supplier collaboration.

Responsabilités

• Lead mechanical engineering activities across the full product lifecycle, from concept through to commercialisation.
• Drive design, development, verification and validation activities for complex medical devices and combination products.
• Collaborate closely with cross-functional teams including R&D, Manufacturing, Quality, Regulatory Affairs and external development partners.
• Support design transfer, manufacturing readiness and technical problem-solving activities.
• Influence product architecture, risk management and design control processes.
• Manage technical documentation and ensure compliance with relevant quality and regulatory requirements.
• Mentor junior engineers and contribute to engineering best practices across the organisation.

Connaissances

Mechanical engineering

Regulatory awareness

Cross-functional collaboration

Design controls

Verification & validation

Description du poste

Senior Mechanical Engineer | Medical Devices | Belgium

Ready to help bring the next generation of combination products from development to commercialisation?

We are supporting an exciting, high-growth organisation as they continue to expand their engineering capabilities in Belgium. With ambitious plans ahead and significant investment in product development, we are seeking an experienced Senior Mechanical Engineer to play a key role in the design, development, and industrialisation of innovative drug-device combination products.

This is an opportunity to join a business at a pivotal stage of growth, where your work will directly influence products progressing towards commercial launch.

What you'll be doing:

• Lead mechanical engineering activities across the full product lifecycle, from concept through to commercialisation
• Drive design, development, verification and validation activities for complex medical devices and combination products
• Collaborate closely with cross-functional teams including R&D, Manufacturing, Quality, Regulatory Affairs and external development partners
• Support design transfer, manufacturing readiness and technical problem-solving activities
• Influence product architecture, risk management and design control processes
• Manage technical documentation and ensure compliance with relevant quality and regulatory requirements
• Mentor junior engineers and contribute to engineering best practices across the organisation

What we're looking for:

• Significant experience in mechanical engineering within the medical device or combination product industry
• Strong understanding of design controls, product development and verification/validation activities
• Experience working within regulated environments (ideally Class IIb and/or Class III medical devices)
• Knowledge of manufacturing processes, industrialisation and supplier collaboration
• Proven ability to work across multidisciplinary teams and manage complex technical challenges
• Exposure to inhalation, respiratory, drug delivery, combination products or other highly engineered medical devices would be advantageous

Why consider this opportunity?

• Join a rapidly growing and heavily invested organisation
• Be part of ambitious product development programmes targeting future commercial launches
• Work on complex, innovative healthcare technologies
• High level of visibility and influence within a growing engineering team
• Long-term career progression opportunities as the organisation continues to scale

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