Medical Device Engineer

MSI Pharma; Town of Belgium (WI); On-site; USD 80,000 - 100,000; Part time

Job summary

MSI Pharma seeks a skilled Medical Device Engineer in the United States, Wisconsin, Town of Belgium, to play a vital role in the design, development, and management of drug delivery systems. This position requires a Bachelor's degree in Engineering or Life Sciences and 3+ years of experience in regulated environments. The ideal candidate will collaborate with cross-functional teams to meet quality standards and ensure compliance with medical device regulations. This is a freelance position with an immediate start for a duration of two years.

Qualifications

• 3+ years’ experience in pharmaceutical, biologics, or medical device environments.
• Exposure to device development and drug delivery systems.
• Understanding of medical device and quality regulations.

Responsibilities

• Support design, development, and lifecycle management of drug delivery systems.
• Collaborate with internal teams and external partners.
• Ensure products meet regulatory, quality, and performance standards.

Skills

Medical Device Regulations

Collaboration

Problem-solving

Organizational Skills

Education

Bachelor’s degree in Engineering or Life Sciences

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 to support the design, development, and lifecycle management of drug delivery systems within a regulated environment. This is a hands‑on technical role contributing across the full product lifecycle, from early‑stage development through to commercialisation and ongoing maintenance. You will work closely with internal teams and external partners to ensure products meet regulatory, quality, and performance expectations.

Requirements

• 3+ years’ experience within pharmaceutical, biologics, or medical device environments
• Exposure to device development, combination products, or drug delivery systems
• Experience working within regulated frameworks (GMP and/or quality systems)
• Involvement in product lifecycle activities (development, validation, or post‑market support)
• Ability to collaborate across cross‑functional teams and external partners
• Strong organisation and prioritisation skills

Hard Skills

• Understanding of medical device and quality regulations (e.g. ISO 13485, 21 CFR 820, MDR, ISO 14971, ICH Q9)
• Knowledge of design and development processes, including verification and validation
• Experience supporting design history file documentation and technical records
• Exposure to regulatory submissions and validation activities
• Understanding of lifecycle management and post‑market activities
• Familiarity with risk management and quality systems
• Project coordination or delivery support experience

Soft Skills

• Strong communication skills and ability to collaborate across teams
• Problem‑solving mindset with the ability to analyse data and draw conclusions
• Ability to work within cross‑functional and matrix environments
• Proactive and organised approach to managing multiple tasks
• Comfortable working in a regulated and structured environment
• Open to feedback and continuous improvement

Education

• Bachelor’s degree in Engineering, Life Sciences, or a related field