Senior Technical Program Lead—Medical Device Manufacturing

Cardinal Health; Juneau (AK); On-site; USD 81,000 - 127,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

401k savings plan

Health savings account (HSA)

Flexible spending accounts (FSAs)

Short- and long-term disability

Work-Life resources

Paid parental leave

Job summary

Cardinal Health is seeking a Principal Engineer - Contract Manufacturing to lead complex design transfer and process development across contract manufacturing sites, coordinating cross-functional teams and ensuring timely execution with strong autonomy.

You will travel up to 50% to CM sites, drive qualification activities (IQ/OQ/PQ), monitor compliance with ISO 13485 and FDA 21 CFR Part 820, and act as program manager for new product launches, delivering scalable, compliant manufacturing

Qualifications

• Bachelor's degree preferred or equivalent in a relevant field.
• Minimum 5 years of experience in regulated industries, preferably medical devices.
• Proven experience leading design transfer activities, process validation (IQ/OQ/PQ), and equipment qualification.
• 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 objectives.
• Willingness to travel ~50% to contract manufacturing sites.

Responsibilities

• Travel frequently to contract manufacturing sites for on-site oversight during design transfer and process development phases.
• Manage and evaluate contract manufacturer performance against service, delivery, quality, compliance, and cost metrics.
• Develop tracking and reporting processes to ensure compliance with audits and regulatory commitments.
• Act as SME for technical, logistical, and operational aspects of projects from initiation to commercialization.
• Coordinate process audits and third-party inspections with on-site support as required.
• Lead or participate in initiatives for process/equipment development and change management at CM sites.
• Serve as program manager for new product launches and supplier onboarding, driving successful transfer and validation.

Skills

Cross-functional leadership

Design transfer

Project management

Process validation

IQ/OQ/PQ

Regulatory knowledge

Travel readiness

Education

Bachelor's degree in a relevant field

Job description

Cardinal Health is seeking a Principal Engineer - Contract Manufacturing to lead complex design transfer and process development across contract manufacturing sites, coordinating cross-functional teams and ensuring timely execution with strong autonomy.

You will travel up to 50% to CM sites, drive qualification activities (IQ/OQ/PQ), monitor compliance with ISO 13485 and FDA 21 CFR Part 820, and act as program manager for new product launches, delivering scalable, compliant manufacturing