Medical Device Engineer Lead: Lifecycle
Il y a 1 jour
Belgique
MSI Pharma
Temps plein
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Location:Braine l'Alleud, BelgiumEngagement:Freelancer, ASAP for 2 yearsOverviewWe’re partnered with a large pharmaceutical organisation to support them in looking for a Medical Device Engineer Lead to take ownership of device programmes, overseeing technical delivery across the full product lifecycle. This role combines technical expertise with leadership responsibility, driving development, industrialisation, and lifecycle management of drug delivery systems while ensuring compliance with regulatory and quality standards. You will act as a key interface across stakeholders, leading technical activities and influencing programme direction.Requirements
- Significant experience within pharmaceutical, biologics, or medical device environments
- Proven track record in device development and lifecycle management
- Experience leading or coordinating cross-functional technical programmes
- Strong understanding of regulatory frameworks and quality systems
- Experience working with external partners and managing technical deliverables
- Ability to influence stakeholders and drive project outcomes
- Deep understanding of medical device and combination product regulations (ISO 13485, MDR, 21 CFR 820, ISO 14971, ICH Q9)
- Expertise in design controls, verification, validation, and process validation
- Strong experience with Design History Files and technical documentation ownership
- Experience contributing to regulatory strategy and submissions
- Lifecycle management expertise, including post-market and continuous improvement activities
- Project management capability across complex technical programmes
- Risk management and quality system leadership experience
- Strong leadership and influencing skills across matrix teams
- Ability to manage complexity, risk, and competing priorities
- Excellent communication and stakeholder engagement skills
- Decision-making capability in high-pressure or ambiguous situations
- Coaching and mentoring mindset to support team development
- Strategic thinking combined with hands-on problem-solving
- Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred)