Principal Engineer, Contract Manufacturing & Design Transfer

Cardinal Health; Helena (MT); On-site; USD 81,000 - 127,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

401k savings plan

Health savings account (HSA)

FSAs

Job summary

Cardinal Health is seeking a Principal Engineer - Contract Manufacturing to lead complex product design and development projects with emphasis on design transfer and process/equipment development at external manufacturing sites. You will coordinate cross-functional teams, oversee CM performance, and drive regulatory compliance through IQ/OQ/PQ and validation activities.

The role requires significant autonomy, frequent travel to CM sites (about 50%), and strong leadership across remote and

Qualifications

• Bachelor's degree in a relevant field preferred.
• Minimum 5 years of related work experience in regulated industries, with preference for medical devices.
• Proven experience leading design transfer activities, IQ/OQ/PQ, and equipment qualification in a regulated environment.
• In-depth knowledge of quality systems (ISO 13485, FDA 21 CFR Part 820) and regulatory requirements for medical devices.
• Demonstrated ability to lead cross-functional teams to achieve operational objectives.
• Ability to travel approximately 50% of the time.

Responsibilities

• Travel frequently to contract manufacturing sites for on-site presence and oversight during design transfer and process development phases.
• Manage and evaluate contract manufacturer performance against metrics for service, delivery, quality, compliance, and cost.
• Develop and maintain tracking and reporting processes to ensure compliance with audit and regulatory commitments.
• Act as SME for technical, logistical, and operational aspects from initiation through commercialization, including design transfer and process validation.
• Coordinate process audits and third-party inspections, providing on-site support as required.
• Contribute to periodic business and operations review meetings.
• Analyze KPIs and support continuous improvement across the supply chain, including CM manufacturing processes.
• Identify and elevate risks and operational issues with contract manufacturers and internal stakeholders.
• Lead problem-solving for production assurance, scheduling, and replanning.
• Lead or coordinate initiatives for capability building, process/equipment development, changes, and corrective actions at CM.
• Act as program manager for new product launches and supplier onboarding, driving design transfer and commercialization with cross-functional teams.

Skills

Cross-functional leadership

Communication

Project management

Travel readiness

Strategic thinking

Negotiation

Interpersonal skills

Education

Bachelor's degree

Certifications such as LSS Black Belt or PMP

Job description

Cardinal Health is seeking a Principal Engineer - Contract Manufacturing to lead complex product design and development projects with emphasis on design transfer and process/equipment development at external manufacturing sites. You will coordinate cross-functional teams, oversee CM performance, and drive regulatory compliance through IQ/OQ/PQ and validation activities.

The role requires significant autonomy, frequent travel to CM sites (about 50%), and strong leadership across remote and