Senior Lead Engineer, Design Quality

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

Summary

Lead Engineer, Design Quality supports the quality assurance efforts during the design and development phase of new products, ensuring compliance with industry standards, regulations, and customer requirements for projects within the Design and Engineering Services Group. Responsibilities span architecture to electronic circuit design, analysis, verification, validation and transfer into manufacturing. The role works across medical device, aerospace & defense, industrial, and smart energy sectors with global team members.

Detailed Responsibilities

• Develop or significantly modify and improve Quality Management Systems; facilitate input for improvement and train teams; participate in QMS planning and scheduling.
• Actively participate in design reviews and design transfers, providing quality and requirements input.
• Develop Design Controls in compliance with 21 CFR 820, ISO 13485, AS9100, and ISO 9001.
• Provide leadership and direction for internal and external Design Audits, address findings and close actions, and offer technical advice to customers regarding audits.
• Guide and support other engineers, sharing best practices and fostering a culture of quality.
• Ensure project deliverables from engineering teams comply with appropriate standards.
• Review and ensure suppliers are in compliance with quality standards and specifications.
• Liaise with regulatory agencies and support product certifications, including FDA and CE marking (EU MDR).
• Create, update, and review product risk management documents (Hazard Analysis, DFMEA, RMP, RMR) in accordance with ISO 14971.

Knowledge, Skills & Competencies

• Project Management: manage and lead complex, multi‑line engineering projects, create project and change management plans, and ensure delivery within time and budget.
• Leadership: demonstrate team leadership behaviors per Celestica Leadership Imperatives.
• Financial Acumen / Business Planning: create financial plans, profit calculations, risk and sensitivity analysis, and understand internal and external financial reporting.
• Coaching/Mentoring, Communication/Negotiation/Presentation, Creative Problem Solving, Customer Interaction/Stakeholder Management, Quality & Lean, Working Effectively with Others, D/PFMEA, 8D/Corrective Action, Equipment Safety, Design of Experiments (DOE).

Technical Skills

• CAPA/RCCA/CI: basic understanding of CAPA and RCCA.
• Design Analysis, Design Process, Design Reviews, DFMEA, Engineering Change Management.
• Industry & Regulatory Standards, Quality Auditing, Quality Data & Statistical Analysis, REQ Management, Risk Assessment, Technical Writing.

Additional Knowledge, Skills and Competencies

• Knowledge of an electronic manufacturing environment, materials, manufacturing, and business processes.
• Ability to evaluate, prioritize, and problem‑solve tasks for timely and accurate completion.
• Fair understanding of quality management systems and processes, including ISO 9001, TL 9001, AS 9100, ISO 13485, ISO 14001, ANSI/ESD 20/20.

Physical Demands

• Duties performed in a normal office environment.
• Extended periods of sitting and sustained visual concentration on a computer monitor or detailed data.
• Frequent repetitive manual movements such as data entry, mouse use, and calculator use.
• Occasional travel may be required.

Salary and Benefits

Salary Range: $95,000 - $126,000 annually.

Benefits: medical, dental, and vision insurance; short‑ and long‑term disability; life insurance; voluntary benefits; 401(k) plan with company match.

Typical Experience

• Four to six years of relevant experience.

Typical Education

• Bachelor’s degree (or technical equivalent) in Mechanical, Electrical, or Software Design.
• Certified Quality Auditor (CQA) certification is a plus.
• Educational requirements may vary by geography.

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.

Equal Employment Opportunity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Celestica’s policy on equal employment opportunity prohibits discrimination based on protected characteristics, including age, marital status, veteran or disability status, and other characteristics protected by law. This policy applies to hiring, promotion, discharge, pay, fringe benefits, job training, classification, referral and other aspects of employment and also states that retaliation against a person who files a charge of discrimination, participates in a discrimination proceeding, or otherwise opposes an unlawful employment practice will not be tolerated. All information will be kept confidential according to EEO guidelines.

Location

This position is located in Maple Grove, Minnesota, USA. The facility is a US ITAR facility and involves the release of export‑controlled goods either directly to employees or through the employee’s movement within the facility. Necessary export control information will be requested upon acceptance of employment.