Senior Lead Engineer, Design Quality & Compliance

Celestica; Maple Grove (MN); On-site; USD 95,000 - 126,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Short-term disability

Long-term disability

Life insurance

Voluntary benefits

401(k) plan with company match

Job summary

Celestica in Maple Grove, Minnesota is seeking a Lead Engineer, Design Quality to drive the quality assurance efforts across the design and development of new products, spanning architecture to electronic circuit design and transfer into manufacturing, with projects in medical device, aerospace & defense, industrial, and smart energy sectors with a global team.

Responsibilities include leading design reviews and design transfers, developing Design Controls per 21 CFR 820, ISO 13485, AS9100 and

Qualifications

• Bachelor's degree in Mechanical, Electrical, or Software Design; related EHS requirements may apply.
• CQA certification is a plus and experience in medical device or aerospace industries is preferred.
• Experience leading multi-discipline engineering projects and audits.

Responsibilities

• Lead design reviews and design transfers, providing quality input.
• Develop Design Controls in accordance with 21 CFR 820, ISO 13485, AS9100, and ISO 9001.
• Oversee internal and external design audits, address findings, and close actions.
• Guide and support other engineers, sharing best practices and fostering a culture of quality.
• Ensure project deliverables comply with standards and supplier quality.
• Liaise with regulatory agencies and support product certifications (FDA, CE).
• Create and review risk management documents per ISO 14971.

Skills

Project Management

Leadership

Financial Acumen

Coaching/Mentoring

Quality & Lean

Design of Experiments

CAPA/RCCA/CI

Risk Assessment

Education

Bachelor's degree in Mechanical, Electrical, or Software Design

Certified Quality Auditor (CQA) is a plus

Tools

DFMEA

Engineering Change Management

Job description

Celestica in Maple Grove, Minnesota is seeking a Lead Engineer, Design Quality to drive the quality assurance efforts across the design and development of new products, spanning architecture to electronic circuit design and transfer into manufacturing, with projects in medical device, aerospace & defense, industrial, and smart energy sectors with a global team.

Responsibilities include leading design reviews and design transfers, developing Design Controls per 21 CFR 820, ISO 13485, AS9100 and