Medical Device Engineer Lead

MSI Pharma; Belgique; On-site; USD 102,762 - 171,271; Full time

Job summary

MSI Pharma seeks a Medical Device Engineer Lead to own device programmes across the full lifecycle. You will drive development, industrialisation, and lifecycle management while ensuring regulatory and quality compliance.

You will interface with stakeholders and external partners, leading technical activities and guiding programme direction. We require a strong track record in medical device environments, leadership of cross-functional teams, and deep knowledge of ISO 13485, MDR, and 21 CFR 820.

Qualifications

• Bachelors in Engineering/Life Sciences; Master’s preferred.
• Experience in medical device or combination product environments.
• Proven track record in device development and lifecycle management.
• Experience leading cross-functional technical programmes.
• Knowledge of regulatory frameworks and quality systems.
• Experience coordinating with external partners.
• Ability to influence stakeholders and drive project outcomes.

Responsibilities

• Own device programmes from concept to post-market.
• Lead development, industrialisation, and lifecycle management.
• Ensure regulatory and quality compliance.
• Act as key interface across stakeholders and partners.
• Drive technical activities and influence programme direction.

Skills

Leadership

Communication

Stakeholder management

Decision making

Strategic thinking

Coaching/mentoring

Education

Bachelor’s degree in Engineering or Life Sciences

Master’s degree preferred

Job description

Location: Braine l'Alleud, Belgium

Engagement: Freelancer, ASAP for 2 years

Overview

We’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

Hard Skills

• 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

Soft Skills

• 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

Education

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s preferred)