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Lead Engineer, Design Quality - Maple Grove, United States - Celestica
Description
Req ID:
Region: Americas
Country: USA
State/Province: Minnesota
City: Maple Grove
**General Overview**
**Job Title:** Senior Lead Engineer, Design Quality
**Functional Area:** Engineering (ENG)
**Career Stream:** Design Quality Engineering
**Role:** Senior Lead Engineer
**Job Code:** ADV-ENG-DQE
**Job Band:** 09
**Direct/Indirect Indicator:** Indirect
**Summary**
**Your new challenge:**
Take your next career step on by joining Celestica as Design Quality Engineer into a multinational company world leader in electronic manufacturing.
You challenge will be connected with the creation from conception, design, build and debug of new products and systems verification for different sectors: health-tech, aerospace and defense, smart energy and industry as our corporate design team is energizing the transformation of society and industry to achieve a more productive and sustainable future.
**Your day- to-day activities will include**
You will be responsible for quality assurance of the design of the different products that our development teams bring to life; from architecture to electronic circuits design and analysis, verification, validation and transfer into manufacturing. The whole design lifecycle.
**Detailed Description**
Performs tasks such as, but not limited to, the following:
+ Guide the quality assurance efforts in the design and development phase of new products in compliance with industry standards, regulations, guidance, and customer requirements
+ Supervising quality design activities and review of any deviations
+ Create/Review product risk management documentation (DFMEA, RMP, RMR, ...) in accordance with ISO 14971
+ Conduct RCA and structured problem solving (CAPA)
+ Support design reviews and transfers
+ Compliance gap analysis
+ Support design reviews and design transfers providing inputs on quality requirements
+ Attend and support internal and external Design Audits
+ Provide guidance and support to other engineers to ensure quality
+ Create and maintain quality plans
+ Support the creation of inspection criteria and risk mitigation strategies
+ Liaison to regulatory agencies and supports product certifications (FDA, FAA, third party test houses, and CE marking bodies)
+ Support QMS leader in maintaining QMS in compliance with 21 CFR820, ISO 13485, ISO 9001
+ Collaborate with suppliers to drive compliance and quality improvements
**Knowledge/Skills/Competencies**
+ Strong knowledge of quality management systems, industry standards (such as ISO 9001, ISO 13485), and regulatory requirements (such as FDA, MDR, RoHS, REACH).
+ Proven experience on product development environment. specifically in the medical/healthcare arena. Solid understanding of electronic product development processes, including design controls, design verification, and validation.
+ Experience with CAPAs handling, Non-conformance, Deviations, Complaints handling (Product Evaluations Reports, Notifications to Competent Authorities)
+ Expertise in conducting risk assessments, failure analysis, and root cause investigations using tools and methodologies such as FMEA, DOE, and 8D.
+ Knowledge of statistical analysis tools
+ Experience in creating design control documentation during the whole lifecycle of the development process
+ Experience with previous transfer of products from design to volume manufacturing
+ Previous experience with PDM tools, product requirements and tracing
+ Ability to work independently, prioritize tasks, and manage multiple projects simultaneously
**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 or 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.
**Typical Experience**
5 to 8 years
**Typical Education**
Bachelor degree minimum
**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.
Celesticas 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.
**COMPANY OVERVIEW:**
Celestica (NYSE, TSX: CLS) enables the worlds best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.
Celestica would like to thank all applicants, however, only qualified applicants will be contacted.
Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.
