Senior Lead Engineer, Design Quality

Summary

The 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 the different projects in the Design and Engineering Services Group; from architecture to electronic circuit design and analysis, verification, validation and transfer into manufacturing. They will work across a wide variety of products and projects in the medical device, aerospace & defense, industrial, and smart energy sectors with team members around the world. The Lead Engineer, Design Quality supports the administering of the Quality Management System and associated quality tools

Detailed Description

Performs tasks such as, but not limited to, the following:

• Develop new or significantly modify and improve Quality Management Systems. Facilitates input for improvement and training of teams.  Participates in QMS planning and scheduling.

• Actively participates in design reviews and design transfers providing inputs on quality and requirements.

• Develops Design Controls in compliance with 21 CFR 820, ISO 13485, AS9100 and ISO 9001. 

• Provide leadership and direction for internal and external Design Audits. Works with extended teams to address findings and close actions. Offers technical advice and feedback to the customers’ technical staff regarding customer/regulatory audits    

• Provide guidance and support to other engineers, sharing best practices and fostering a culture of quality.

• Ensures project deliverables from engineering teams are compliant with the appropriate standards.

• Review and ensure suppliers are in compliance with quality standards and specifications. 

• Liaison to regulatory agencies and supports product certifications.  Support the submissions to 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 - Ability to manage/lead complex, multiple line engineering projects that may also involve other functions. Demonstrate solid understanding of the technical, financial and people aspects of the project. Able to create a project/change management plan and ensure that the project is delivered within the assigned time and budget. Ability to recognize project barriers and develop mitigation plans

  • Leadership - Demonstrate "People & Team Leadership Behaviors" as per Celestica Leadership Imperatives. Our engineers lead by making the team around them better. We serve each other and our customers by listening first, adapting to deliver, building quality relationships, and working with integrity.

  • Financial Acumen / Business Planning - Ability to create financial plans for your projects, align them internally with your line of management and other functions and externally if needed. Create project plans, profitability calculations, risk and sensitivity analysis, able to recognize barriers and mitigate profitability risks. Fully knowledgeable about internal and external financial reporting, accounting and tax requirements relevant to your area of expertise.

  • The following competencies may also be required: 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 CAPA and RCCA
• Design Analysis
• Design Process
• Design Reviews
• DFMEA
• Engineering Change Management
• Industry & Reg Industry Standards
• Quality Auditing
• Quality Data & Stat Analysis
• REQ Management
• Risk Assessment
• Technical Writing

Additional knowledge, skills and competencies include:

• Knowledge of an electronic manufacturing environment, materials, manufacturing and business processes.

• Ability to evaluate, prioritize and problem solve a variety of tasks to ensu