Senior Lead Engineer, Design Quality

Celestica International LP•Maple Grove, MN

9d•$95,000 - $126,000•Onsite

About The Position

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.

Requirements

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.
CAPA/RCCA/CI: Basic understanding CAPA and RCCA
Design Analysis
Design Process
Design Reviews
DFMEA
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 ISO9001, TL9001, AS9100, ISO13485, ISO14001, ANSI/ESD 20/20

Nice To Haves

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)
CQA = Certified Quality Auditor is a plus

Responsibilities

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.