Engineering Project Manager – Medical Devices

Key Responsibilities

• Lead quality engineering activities supporting global product transfers, manufacturing expansions, and new production line implementations.
• Provide technical leadership for quality engineering activities involving manufacturing processes, equipment, utilities, facilities, and validation programs.
• Partner with Engineering, Manufacturing, Validation, Regulatory Affairs, Quality Systems, and Development teams to ensure successful execution of projects.
• Develop and execute validation and qualification strategies while ensuring compliance with cGMP, regulatory requirements, and AbbVie Quality Systems.
• Lead quality oversight for process validation, equipment qualification, cleaning validation, utilities, computerized systems, and manufacturing processes.
• Drive risk assessments, quality investigations, compliance initiatives, and implementation of corrective and preventive actions.
• Review manufacturing processes and quality systems to identify compliance gaps and implement risk-based solutions.
• Support change controls, product transfers, and process improvements while maintaining product quality and regulatory compliance.
• Communicate project status, quality metrics, risks, and recommendations to leadership and executive stakeholders.
• Manage project priorities, functional resources, and budgets to support successful project execution.

Required Qualifications

• Bachelor's or Master's degree in Engineering or a related scientific discipline (Engineering strongly preferred).
• Certified Project Manager (CPM) certification highly preferred.
• Demonstrated experience leading global product transfer projects within the medical device industry.
• Hands-on experience supporting manufacturing engineering activities and implementation of new production lines.
• Strong understanding of quality engineering principles, validation, qualification, and cGMP regulations.
• Experience collaborating across Manufacturing, Engineering, Quality, Regulatory, and Validation organizations.
• Excellent verbal and written communication skills with the ability to effectively present to leadership and cross-functional teams.
• Ability to travel approximately 10–15% internationally to Costa Rica.

Preferred Qualifications

• 8+ years of experience in Quality Engineering, Manufacturing, Quality Assurance, Quality Control, R&D, or related functions within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industry.
• 4+ years of project leadership, technical leadership, or people management experience.
• Experience supporting validation lifecycle activities including process, equipment, cleaning, utility, computerized systems, or method validation.
• Knowledge of statistical quality systems, electronic quality management systems, laboratory information management systems (LIMS), and quality risk management principles.
• Demonstrated ability to lead complex cross-functional initiatives while balancing quality, compliance, project timelines, and business objectives.

Ideal Candidate

The ideal candidate is a collaborative engineering leader who combines strong project management skills with hands-on quality engineering expertise.

They have successfully managed global product transfers within the medical device industry, understand manufacturing startup and production line implementation, and can effectively partner with global cross-functional teams to deliver compliant, high-quality manufacturing solutions.

Strong communication, leadership, and organizational skills are essential, along with the ability to influence stakeholders and drive projects to completion in a fast-paced, regulated environment.