Senior Lead Engineer, Manufacturing Process
Celestica
Assembly
Quality Engineer
Flex
full-time
Posted on:
Location Type: Office
Location: Buffalo Grove • Illinois • 🇺🇸 United States
Visit company websiteSalary
💰 $74,500 - $102,500 per year
Job Level
Mid-LevelSenior
Tech Stack
Assembly
About the role
- Develops and initiates standards and methods for inspection, testing and evaluation
- Devises sampling procedures and designs forms and instructions for recording, evaluating and reporting quality and reliability data
- Develops and implements methods and procedures for disposition of discrepant material and devises methods to assess cost
- Directs workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability
- Compiles and writes training material and conducts training sessions on quality control activities
- Holds up Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues
- Assures data availability and integrity for all quality related data and consolidates and reports quality results
- Initiates corrective action requests as needed and tracks to satisfactory completion; assists with development and implementation of quality audits
- Develops, applies, revises and maintains quality standards for processing materials into partially finished or finished products
- Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
- Explores reports and returned products and recommends corrective action; establishes program to evaluate precision and accuracy of production equipment and testing, measurement and research of equipment and facilities
- Approves product, process and equipment qualifications and provides liaison to various regulatory bodies
Requirements
- Bachelor’s degree in Mechanical or Automation Engineering
- 3+ years of experience in Medical Device manufacturing
- Demonstrates advanced technical, operational, and process skills, including change control, non-conformance and CAPA management
- Statistical data analysis experience (e.g., Minitab)
- Deep understanding of standards, policies, and interdependent functional technologies
- Strong working knowledge of 21CFR820 QMSR and ISO 13485 2016
- Advanced mathematical and analytical skills (exponents, logarithms, quadratic equations, permutations, statistical techniques, ANOVA, correlation, sampling theory, factor analysis)
- Skilled in interpreting technical instructions in mathematical or diagram form and managing abstract and concrete variables
- Experience with electronic assembly (color codes, schematics, PCB operations) and testing tools (oscilloscope, logic analyzer, component diagnostics)
- Experience with inspection tools (microscope, measuring instruments) and mechanical/electrical tools (taps, dies, alignment tools)
- Proficiency with office software (word processing, spreadsheets, presentations)
Benefits
- Full range of medical, dental, and vision plans
- Life Insurance
- Short-term and Long-term Disability
- Matching 401(k) Contributions
- Vacation and Paid Sick Time
- Tuition Reimbursement
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
statistical data analysischange controlnon-conformance managementCAPA managementmathematical skillsanalytical skillsquality standardsinspection methodstesting methodsevaluation methods
Soft skills
training material developmentcommunicationproblem-solvingleadershipdata integrity management
Certifications
Bachelor’s degree in Mechanical EngineeringBachelor’s degree in Automation EngineeringISO 13485 2016
