Req ID: 137714
Region: Americas
Country: USA
State/Province: Minnesota
City: Maple Grove
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:
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Develop new or significantly modify and improve Quality Management Systems. Facilitates input for improvement and training of teams. Participates in QMS planning and scheduling.
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Actively participates in design reviews and design transfers providing inputs on quality and requirements.
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Develops Design Controls in compliance with 21 CFR 820, ISO 13485, AS9100 and ISO 9001.
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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
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Provide guidance and support to other engineers, sharing best practices and fostering a culture of quality.
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Ensures project deliverables from engineering teams are compliant with the appropriate standards.
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Review and ensure suppliers are in compliance with quality standards and specifications.
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Liaison to regulatory agencies and supports product certifications. Support the submissions to FDA and CE Marking (EU MDR)
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Create, update and review product risk management documents (Hazard analysis, DFMEA, RMP, RMR) in accordance with ISO 14971.
Knowledge/Skills/Competencies
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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
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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.
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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.
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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:
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Knowledge of an electronic manufacturing environment, materials, manufacturing and business processes.
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Ability to evaluate, prioritize and problem solve a variety of tasks to ensure their timely and accurate completion.
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Fair understanding of quality management systems and processes, including ISO9001, TL9001, AS9100, ISO13485, ISO14001, ANSI/ESD 20/20
Physical Demands
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Duties of this position are performed in a normal office environment.
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Duties may require extended periods of sitting and sustained visual concentration on a computer monitor or on numbers and other detailed data.
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Repetitive manual movements (e.g., data entry, using a computer mouse, using a calculator, etc.) are frequently required.
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Occasional travel may be required.
Salary
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
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Bachelor's degree (or Technology equivalent) in relevant field such as Mechanical/ Electrical/ Software design
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CQA = Certified Quality Auditor is a plus
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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.
COMPANY OVERVIEW: Celestica, Inc. (NYSE: CLS; TSX: CLS) is a technology leader dedicated to driving customer success and market advancements. With deep expertise in design, engineering, manufacturing, supply chain, and platform solutions, Celestica enables critical data center infrastructure for AI, cloud, and hybrid cloud and advances technologies in high-growth markets. With a talented team and a strategic global network, Celestica helps its customers achieve competitive advantages.
Today, Celestica delivers innovative supply chain solutions globally to customers in strategic two operating and reporting segments: Advanced Technology Solutions (ATS) and Connectivity and Cloud Solutions (CC):
ATS: This segment serves customers in complex, regulated and high-reliability markets such as Industrial & Smart Energy, Aerospace & Defense, Semiconductor Capital Equipment, and HealthTech. It is engineering led, with deep expertise in design, manufacturing and lifecycle solutions.
CCS: This segment focuses on high-performance technology solutions and services for the data center, serving hyperscalers, digital native customers and enterprises. Celestica's Platform Solutions offering provides innovative and customizable computing, storage and networking solutions enabling AI-driven growth.
Built on a legacy of trust and performance, Celestica has earned its reputation by delivering results in complex and fast-changing markets. Celestica exceeds customer expectations by identifying trends and staying ahead of the curve. Backed by comprehensive capabilities and a global network across North America, Europe and Asia, Celestica helps customers gain competitive advantage with the quality, flexibility and resiliency they need to respond quickly to shifts in demand. Guided by a bold vision to accelerate market advancements, Celestica delivers innovative solutions and technologies that turn complexity into opportunity. Anchored in teamwork and commitment, Celestica strives to be the most trusted partner to its customers and colleagues worldwide.
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.
This location is a US ITAR facility and these positions will involve the release of export controlled goods either directly to employees or through the employee's movement within the facility. As such, Celestica will require necessary information from all applicants upon an applicant's acceptance of employment to determine if any export control exemptions or licenses must be filed.
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