Medtronic
Overview
Join to apply for the
Sr. Quality Engineer
role at
Medtronic . Medtronic is seeking a highly skilled Senior Hardware Quality Engineer to join our innovative team. The ideal candidate has a strong background in hardware engineering, reliability testing, quality assurance, and regulatory compliance within the medical device industry. This role will be pivotal in ensuring the development and maintenance of high-quality, reliable, and safe medical devices that meet regulatory standards and customer expectations.
A Day in the Life
Medtronic, a global leader in medical technology, services, and solutions, is seeking a Senior Hardware Quality Engineer to join our team. This role focuses on leading quality assurance processes, design verification, regulatory compliance, and cross-functional collaboration to maintain product quality throughout the lifecycle.
Responsibilities Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards.
Define and manage sub-systems requirements to ensure clarity, completeness, and testability. Define requirements and assess risk through the use of DFMEA/DFMECA.
Support engineering teams in the development of Critical to Function (CTF) matrices for identification of critical functions and linking these functions to design requirements.
Plan, execute, and document design verification activities to ensure product designs meet specified requirements and regulatory standards.
Support design, technical, and print reviews as part of the design verification process.
Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports.
Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure products meet requirements.
Ensure compliance with relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections.
Evaluate product reliability through reliability assessments and test systems development.
Collaborate with cross-functional teams (R&D, manufacturing, NPD, regulatory affairs) to define and implement hardware engineering processes that ensure product quality and compliance throughout the product lifecycle.
Minimum Requirements Bachelor’s degree in Engineering or a related technical field and 4 years of relevant experience, or a Master’s degree and 2 years of relevant experience.
Nice to have Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification.
Experience: Quality Assurance, Engineering.
Industry Experience: Medical device industry.
Technical Skills: Proficient in hardware engineering methodologies, quality assurance practices, design verification, DFMECA, and regulatory compliance.
Physical Job Requirements
The physical demands described are representative of those necessary to perform the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. For office roles, candidates are regularly required to be independently mobile, interact with a computer, and communicate with peers and co-workers.
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. Details below are typical information for U.S. locations and may vary by location and experience.
Salary ranges for U.S. locations (USD): $96,800.00 - $145,200.00
Eligible for a short-term incentive plan (MIP).
Base salary range applies across the United States, with adjustments for experience, certification, education, market conditions, and location.
Benefits for regular employees working 20+ hours per week include Health, Dental, Vision, HSA, FSA, Life Insurance, Disability, 401(k) with company match, PTO, holidays, Employee Stock Purchase Plan, and other programs.
Medtronic is an equal employment opportunity employer. We provide reasonable accommodations for qualified individuals with disabilities. See our EEO statement for more information.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ people. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people.
If you would like to learn more about our business, mission, and commitment to diversity, please review our career information and resources.
Note: This posting summarizes the role and does not include every duty and responsibility of the position.
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Join to apply for the
Sr. Quality Engineer
role at
Medtronic . Medtronic is seeking a highly skilled Senior Hardware Quality Engineer to join our innovative team. The ideal candidate has a strong background in hardware engineering, reliability testing, quality assurance, and regulatory compliance within the medical device industry. This role will be pivotal in ensuring the development and maintenance of high-quality, reliable, and safe medical devices that meet regulatory standards and customer expectations.
A Day in the Life
Medtronic, a global leader in medical technology, services, and solutions, is seeking a Senior Hardware Quality Engineer to join our team. This role focuses on leading quality assurance processes, design verification, regulatory compliance, and cross-functional collaboration to maintain product quality throughout the lifecycle.
Responsibilities Lead and mentor teams in the development, implementation, and maintenance of quality assurance processes and standards.
Define and manage sub-systems requirements to ensure clarity, completeness, and testability. Define requirements and assess risk through the use of DFMEA/DFMECA.
Support engineering teams in the development of Critical to Function (CTF) matrices for identification of critical functions and linking these functions to design requirements.
Plan, execute, and document design verification activities to ensure product designs meet specified requirements and regulatory standards.
Support design, technical, and print reviews as part of the design verification process.
Ensure thorough and accurate documentation of quality assurance activities, including test results, risk assessments, and compliance reports.
Oversee validation and verification activities, including the development of test plans, protocols, and reports to ensure products meet requirements.
Ensure compliance with relevant regulatory requirements, including FDA, ISO, and other international standards, and participate in regulatory audits and inspections.
Evaluate product reliability through reliability assessments and test systems development.
Collaborate with cross-functional teams (R&D, manufacturing, NPD, regulatory affairs) to define and implement hardware engineering processes that ensure product quality and compliance throughout the product lifecycle.
Minimum Requirements Bachelor’s degree in Engineering or a related technical field and 4 years of relevant experience, or a Master’s degree and 2 years of relevant experience.
Nice to have Certifications: Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification.
Experience: Quality Assurance, Engineering.
Industry Experience: Medical device industry.
Technical Skills: Proficient in hardware engineering methodologies, quality assurance practices, design verification, DFMECA, and regulatory compliance.
Physical Job Requirements
The physical demands described are representative of those necessary to perform the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. For office roles, candidates are regularly required to be independently mobile, interact with a computer, and communicate with peers and co-workers.
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. Details below are typical information for U.S. locations and may vary by location and experience.
Salary ranges for U.S. locations (USD): $96,800.00 - $145,200.00
Eligible for a short-term incentive plan (MIP).
Base salary range applies across the United States, with adjustments for experience, certification, education, market conditions, and location.
Benefits for regular employees working 20+ hours per week include Health, Dental, Vision, HSA, FSA, Life Insurance, Disability, 401(k) with company match, PTO, holidays, Employee Stock Purchase Plan, and other programs.
Medtronic is an equal employment opportunity employer. We provide reasonable accommodations for qualified individuals with disabilities. See our EEO statement for more information.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ people. We are engineers at heart, putting ambitious ideas to work to generate real solutions for real people.
If you would like to learn more about our business, mission, and commitment to diversity, please review our career information and resources.
Note: This posting summarizes the role and does not include every duty and responsibility of the position.
#J-18808-Ljbffr