Senior Contract Manufacturing Engineer - Design Transfer

Cardinal Health; Augusta (ME); 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

HSA access

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Career development programs

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 sites. You will coordinate cross-functional teams, manage execution, and drive successful transfer, validation, and commercialization.

The role requires significant autonomy, strong leadership across remote and in-person teams, and travel up to 50% to contract manufacturers and sites.

Qualifications

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

Responsibilities

• Travel frequently to contract manufacturing sites for on-site presence and oversight.
• 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 audits and regulatory commitments.
• Serve as the subject matter expert for technical, logistical, and operational aspects of projects through commercialization.
• Coordinate process audits and third-party inspections, providing on-site support as required.
• Lead problem-solving for production assurance, scheduling, and replanning.

Skills

Cross-functional leadership

Design transfer

Process validation IQ/OQ/PQ

Regulatory compliance

Contract manufacturing oversight

Education

Bachelor's degree in a relevant field

LSS Black Belt or PMP (preferred)

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 sites. You will coordinate cross-functional teams, manage execution, and drive successful transfer, validation, and commercialization.

The role requires significant autonomy, strong leadership across remote and in-person teams, and travel up to 50% to contract manufacturers and sites.