Senior Engineer - Design Transfer & CM Operations

Cardinal Health; Cheyenne (WY); On-site; USD 81,000 - 127,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking a Principal Engineer - Contract Manufacturing to lead complex product design and development projects, focusing on design transfer and process/equipment development at contract manufacturing sites. You will coordinate cross-functional resources and manage execution with significant autonomy.

Travel to sites is frequent (about 50%). You will oversee supplier performance, audits, and risk management to ensure successful design transfer, process validation, and

Qualifications

• 5+ years of related work experience in regulated industries.
• Experience leading design transfer activities, and IQ/OQ/PQ, and equipment qualification in a regulated environment.
• In-depth knowledge of ISO 13485 and FDA 21 CFR Part 820 and related regulatory requirements.
• 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 service, delivery, quality, compliance, and cost.
• Develop and maintain tracking and reporting processes for audits and regulatory commitments.
• Serve as SME for technical, logistical, and operational project aspects from initiation through commercialization.
• Coordinate process audits and third-party inspections, providing on-site support.
• Contribute to periodic business and operations review meetings.
• Analyze KPIs and support continuous improvement across supply chain and CM processes.
• Identify and escalate risks and issues with contract manufacturers and stakeholders.
• Lead or coordinate initiatives for capability building, process development, and changes at CMs.
• Act as program manager for new product launches and supplier onboarding.

Skills

Design transfer

Process validation

Equipment qualification

Cross-functional leadership

Regulatory compliance

Quality systems

Travel 50%

Education

Bachelor's degree in a relevant field

LSS Black Belt or PMP

Job description

Cardinal Health is seeking a Principal Engineer - Contract Manufacturing to lead complex product design and development projects, focusing on design transfer and process/equipment development at contract manufacturing sites. You will coordinate cross-functional resources and manage execution with significant autonomy.

Travel to sites is frequent (about 50%). You will oversee supplier performance, audits, and risk management to ensure successful design transfer, process validation, and