Senior Lead Engineer, Design Quality

Celestica Inc.; Maple Grove (MN); On-site; USD 95,000 - 126,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

401k plan

Job summary

Celestica Inc. is seeking a Senior Lead Engineer, Design Quality to drive design quality activities across multiple programs. You will lead design controls, participate in design reviews and audits, and guide risk management and regulatory submissions for medical, aerospace/defense, and industrial projects.

You will work with global teams to ensure compliance with ISO 13485, 21 CFR 820, and related standards while developing robust QMS processes and mentoring engineers in quality best practices.

Qualifications

• Four to six years of relevant experience in quality engineering.
• Experience with design controls and regulatory standards.
• Knowledge of ISO13485, ISO9001, AS9100, TL9001, ISO14971 is a plus.

Responsibilities

• Support quality assurance during design and development of new products.
• Participate in QMS planning, scheduling and design reviews.
• Develop and improve Design Controls per 21 CFR 820, ISO 13485, AS9100, ISO 9001.
• Lead internal and external design audits and address findings.
• Provide guidance on risk management and regulatory submissions.
• Create and review risk management documents (Hazard analysis, DFMEA, RMP, RMR).
• Collaborate with regulators and customers on audits and certifications.
• Manage projects with budget/time within scope; mentor engineers.
• Ensure compliance of suppliers with standards and specifications.

Skills

CAPA/RCCA/CI

Design Analysis

Design Process

Design Reviews

DFMEA

Quality Auditing

Quality Data & Statis Analysis

REQ Management

Technical Writing

Electronic manufacturing knowledge

Education

Bachelor's in Mechanical/Electrical/Software design

CQA certification (plus)

Job description

Senior Lead Engineer, Design Quality

Date: Jul 13, 2026

Location: Maple Grove, MN, US

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

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.

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
• Quality Auditing
• Quality Data & Stat Analysis
• REQ Management
• 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 ISO9001, TL9001, AS9100, ISO13485, ISO14001, 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.

The salary range described in this posting is an estimate by the Company, and may change based on several factors, including by not limited to a change in the duties covered by the job posting, or the credentials, experience or geographic jurisdiction of the successful candidate. Salary Range: $95,000-$126,000 Annually

Celestica 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

CQA = Certified Quality Auditor 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.

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 race, color, creed, religion, national origin, gender, sexual orientation, gender identity, age, marital status, veteran or disability status, or 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.