Senior Lead Engineer, Design Quality

Senior Lead Engineer, Design Quality

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:

• 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.
• Leadership
  - Demonstrate "People & Team Leadership Behaviors" as per Celestica Leadership Imperatives.
• 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.
• 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
• 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 ensure their timely and accurate completion. Fair understanding of quality management systems and processes, including ISO
9001, TL9001, AS9100, ISO
13485, ISO
14001, ANSI/ESD 20/20

Physical Demands:

• Duties of this position are performed in a normal office environment.
• Duties may require extended periods of sitting and sustained visual concentration on a computer monitor or on numbers and other detailed data.
• Repetitive manual movements (e.g., data entry, using a computer mouse, using a calculator, etc.) are frequently required.
• Occasional travel may be required.

Salary Range: $95,000-$126,000 Annually

Celstica provides eligible employees (those who are scheduled to work 30 hours or more per week) with a range of benefits including medical insurance, dental insurance, vision insurance, short and long term disability, life insurance, voluntary benefits and a 401k plan with company match.

Typical

Experience:

Four to six years of relevant experience

Typical

Education:

Bachelor's degree (or Technology equivalent) in relevant field such as Mechanical/ Electrical/ Software design

Celstica's policy on equal employment opportunity prohibits discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Celstica would like to thank all applicants, however, only qualified applicants will be contacted.