Senior Lead Engineer, Design Quality

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.

• 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.

• 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).

• 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.

• 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.

• 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 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.

• Four to six years of relevant experience.

• 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.

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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender…