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Principal Device Development Assurance Scientist/Engineer - Job Opportunity at McDermott Laboratories Limited (Viatris)

Dublin, Ireland
Full-time
Senior
Posted: January 25, 2025
On-site
EUR 85,000 - 110,000 per year based on Dublin market rates for senior medical device roles

Benefits

Competitive salary with performance bonus structure
Comprehensive health insurance coverage
Retirement pension plan
Career development and progression opportunities
Work-life balance initiatives

Key Responsibilities

Lead design control implementation for combination products and medical devices
Establish and maintain Design History Files for development programs
Drive compliance with FDA and EU regulatory requirements
Manage risk assessment and ISO 14971:2019 implementation
Support regulatory submissions and audit preparation
Provide technical guidance across global development teams

Requirements

Education

Degree / Masters in engineering or science/life science

Experience

5-7 years in similar level/ or 5-10 years general experience in industry

Required Skills

Direct experience in device development and manufacturing operations Understanding of GMP and Quality Management Systems Knowledge of FDA/EU regulations (21 CFR 820, 21 CFR Part 4, EU 2017/745) Familiarity with ISO standards (ISO13485, ISO14971) Strong problem solving and analytical skills Excellent communication abilities Team collaboration capabilities
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Sauge AI Market Intelligence

Industry Trends

Increasing focus on combination products and drug delivery devices in pharma Growing regulatory scrutiny in medical device development Rising demand for autoinjectors and self-administration devices Shift towards digital integration in medical devices Emphasis on sustainability in device development

Role Significance

Likely part of a 10-15 person development team with matrix reporting structure
Senior technical position with significant influence on product development and compliance strategy

Key Projects

Design control implementation for novel drug delivery devices Technical due diligence for product acquisitions Regulatory submission preparation Quality system enhancement initiatives

Success Factors

Deep understanding of regulatory landscape Ability to influence cross-functional teams Strategic thinking in risk management Strong documentation and technical writing skills Effective stakeholder management across multiple sites

Market Demand

High demand driven by expanding biologics market and need for sophisticated delivery systems

Important Skills

Critical Skills

Regulatory compliance expertise in both EU and US frameworks Design control implementation experience Risk management proficiency Technical documentation capabilities

Beneficial Skills

Experience with digital health technologies Knowledge of human factors engineering Understanding of manufacturing processes Project management skills

Unique Aspects

Global device development spanning four major R&D sites
Extensive combination product portfolio
Strong focus on innovative delivery systems
Significant involvement in product acquisitions and integration

Career Growth

2-4 years typical progression timeline with demonstrated success

Potential Next Roles

Device Development Director Technical Operations Leader Quality Systems Manager Regulatory Affairs Director

Company Overview

McDermott Laboratories Limited (Viatris)

Global pharmaceutical company formed from Mylan and Upjohn merger, focused on both generic and branded medications

Major player in global generics and biosimilars market with significant R&D capabilities
Strategic European hub for device development with global influence
Matrix organization emphasizing collaboration across global sites with focus on innovation and compliance
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