Principal Engineer - Contract MFG

Socket.dev; Field (KY); On-site; USD 81,000 - 127,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

HSA

401k savings plan

Employee wellness programs

Paid parental leave

Life insurance

Disability coverage

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 external sites. The role requires strong leadership across remote and in-person teams, with high autonomy and the ability to manage multiple concurrent programs to deliver strategic and operational results.

The position emphasizes cross‑functional collaboration, regulatory knowledge (ISO 13485, FDA 21

Qualifications

• Bachelor's degree preferred.
• Minimum of 5 years in regulated industries, with medical devices preferred.
• Experience leading design transfer activities, IQ/OQ/PQ, and equipment qualification in regulated environments.
• Knowledge of ISO 13485 and FDA 21 CFR Part 820 requirements.
• Strong leadership and cross‑functional collaboration capabilities.
• 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.
• Manage and evaluate contract manufacturer performance against metrics for service, delivery, quality, compliance, and cost.
• Develop and maintain tracking and reporting processes to ensure audit and regulatory commitments.
• Act as SME for technical, logistical, and operational aspects from initiation to commercialization.
• Coordinate process audits and third‑party inspections with on-site support.

Skills

Leadership

Project management

Cross-functional

Travel 50%

Education

Bachelor's degree

Job description

Job Summary

The Principal Engineer - Contract Manufacturing leads complex product design and development projects, with a particular emphasis on design transfer and process/equipment development at external manufacturing sites. This role is responsible for coordinating cross-functional resources and managing project execution to ensure successful completion. The position requires effective leadership across remote and in-person teams, significant autonomy, and the ability to manage multiple concurrent projects to deliver strategic and operational results.

Responsibilities

• Travel frequently to contract manufacturing sites for on-site presence and oversight, particularly 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 internal and external audit requirements and regulatory commitments.
• Serve as the subject matter expert for technical, logistical, and operational aspects of projects from initiation through commercialization, including design transfer and process/equipment validation.
• Coordinate process audits and third-party inspections, providing on-site support as required.
• Contribute to the preparation of periodic business and operations review meetings.
• Analyze key performance indicators and support continuous improvement initiatives across the supply chain, including manufacturing processes at CMs.
• Identify and elevate risks and operational issues with contract manufacturers and internal stakeholders.
• Lead problem‑solving efforts related to production assurance, scheduling, and replanning.
• Lead or coordinate initiatives for capability building, process and equipment development, product changes (introduction/exit), and corrective actions at contract manufacturers.
• Act as a program manager for new product launches and supplier onboarding, driving successful design transfer, process validation, and commercialization with cross‑functional teams.

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 (e.g., ISO 13485, FDA 21 CFR Part 820) and relevant regulatory requirements for medical devices.
• Demonstrated ability to lead cross‑functional teams to achieve operational objectives.
• Ability to contribute to strategic goal‑setting for the department or business unit.
• Exceptional communication, negotiation, and interpersonal skills for effective collaboration with internal teams and external contract manufacturers.
• Ability to travel approximately 50% of the time.

Anticipated salary range:$80,900 - $127,050

Bonus eligible:No

Benefits:Cardinal Health offers a wide variety of benefits and programs to support health and well‑being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long‑term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close:9/6/26

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back‑to‑work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.