Engineering Project Manager – Medical Devices

Engineering Project Manager – Medical Devices
(QA Engineering Project Manager)

Location: North Chicago, IL (Hybrid – Tuesday, Wednesday & Thursday onsite)
Travel: Approximately 10–15% travel to Costa Rica if needed 
Duration: 1-Year Contract
Pay Rate: $60-$64/hr based on benefit selection

Orion Group is seeking an experienced Engineering Project Manager – Medical Devices to support a global pharmaceutical and medical device organization. This position will lead complex quality engineering initiatives supporting global product transfers, manufacturing expansion, and new production line implementation. The successful candidate will provide technical leadership while remaining hands-on in driving quality, validation, compliance, and engineering activities across cross-functional teams.
This role is ideal for an experienced engineering professional with a background in medical device manufacturing who has successfully managed global product transfers and enjoys collaborating with engineering, manufacturing, quality, and regulatory partners in a highly regulated environment.

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.

People are our business worldwide
 
Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.