Quality Engineer II
5 days ago
Job Title: Software Quality Engr II
Type: Contract - Job Title: Software Quality Engineer II (Medical Device)
Type: Contract- 6 Months
Day Shift
Location:250 Medtronic Dr Bldg 1, Lafayette, CO
Pay: Can Be Flexible
What product line will this person support? Stealth Station in Navigation business unit.
We are seeking a Software Quality Engr II for a very important client.
This position has the opportunities to work with corss-functional team members to support Post Market Software related activities:
Post Market Release lifecycle, such as remediation, CAPA, and other activities as assigned.
Responsibilities may include but not limited to the following activities, with mentor/coach/guidance from more senior Software quality engineers:
Supports product quality ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices.
Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
Reviews software systems design, change specifications, and plans against process requirements.
Collaborate with test engineering on verification and validation strategies, review and approve test protocols and reports.
The ideal candidate must possess the following qualifications:
Top 3 technical skills that are required for the role:
Requirements Analysis and Management: This skill is crucial for evaluating product definition requirements, ensuring that software product requirements are clear, complete, and testable, and assessing test coverage with respect to requirements and design outputs.
Software Documentation and Specification: The ability to review and remediate design output documentation, such as software architecture documentation and software form and behavior specifications, is key. This includes ensuring these documents meet intended use and performance criteria.
Quality Assurance and Compliance: Knowledge and experience in quality assurance practices, especially related to following Quality System Practices and meeting FDA, ISO, and European Medical Device standards and regulations, are essential. This includes identifying design-related gaps and implementing mitigation strategies.
Years’ Experience Required: Bachelor’s Degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 0+ years of work experience in Engineering and/or Quality.
Nice to Have
Experience in the medical device industry
Experience with FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards
Navigation systems experience preferred
Excellent oral and written communication skills
Benefits include:
-MEC/ACP Medical
-Voluntary Dental, Vision, Life, Supplemental Income
-401k (must meet requirements)
-sick leave as required by state/county
-
Engineer, Quality II
1 month ago
Lafayette, United States Southwire Full timeEngineer, Quality II Apply now » Date: Nov 15, 2024 Location: Lafayette, IN, US, 47905 Company: Southwire Company LLC A leader in technology and innovation, Southwire Company, LLC is one of North America’s largest wire and cable producers. Southwire and its subsidiaries manufacture building wire and cable, metal-clad cable, portable and electronic...
-
Engineer, Quality II
3 weeks ago
Lafayette, United States Southwire Full timeEngineer, Quality II Apply now » Date: Dec 14, 2024 Location: Lafayette, IN, US, 47905 Company: Southwire Company LLC A leader in technology and innovation, Southwire Company, LLC is one of North America’s largest wire and cable producers. Southwire and its subsidiaries manufacture building wire and cable, metal-clad cable, portable and electronic...
-
Software Quality Engineer II
2 days ago
Lafayette, United States Redbock - an NES Fircroft company Full timeSoftware Quality Engineer II (6-month contract, opportunity for extension // Lafayette, CO):Top 3 Skills:Requirements Analysis and Management: This skill is crucial for evaluating product definition requirements, ensuring that software product requirements are clear, complete, and testable, and assessing test coverage with respect to requirements and design...
-
Software Quality Engineer II
2 days ago
Lafayette, United States Redbock - an NES Fircroft company Full timeSoftware Quality Engineer II (6-month contract, opportunity for extension // Lafayette, CO):Top 3 Skills:Requirements Analysis and Management: This skill is crucial for evaluating product definition requirements, ensuring that software product requirements are clear, complete, and testable, and assessing test coverage with respect to requirements and design...
-
Quality Engineer II
5 months ago
Lafayette, United States LanceSoft Full timeMust Have: CAPA JOB DESCRIPTION Quality Engineer II: Responsibilities may include the following and other duties may be assigned. A representative for the Released Product Management (RPM) Design Quality team on projects that address day-to-day quality issues of the market-released products. Compliance effective oversight with the RPM activities per the...
-
Field Engineer II
2 months ago
Lafayette, United States Core Group Resources Careers Full timeCore Group Resources is America's leading recruitment company. Founded by a service academy graduate who has offshore experience, Core Group Resources' expertise is unmatched in the marine offshore market, finance, IT, renewables, & non-profit for executive search, staffing, and expertise identification.*Field Engineer II Job Summary* We are seeking a Field...
-
Manufacturing Engineer II
5 days ago
Lafayette, United States Grove Technical Resources, INC Full timeJob Title - Manufacturing Engineer IIJob Location - Lafayette, ColoradoJob DescriptionCan you please confirm the 3 main responsibilities/day to day activities required for this role?Design development and production fixtures for assembly and test of medical devices. Support product design engineers with prototype builds. Support qualification and...
-
Manufacturing Engineer II
6 days ago
Lafayette, United States Grove Technical Resources, INC Full timeJob Title - Manufacturing Engineer IIJob Location - Lafayette, ColoradoJob DescriptionCan you please confirm the 3 main responsibilities/day to day activities required for this role?Design development and production fixtures for assembly and test of medical devices. Support product design engineers with prototype builds. Support qualification and...
-
Engineer, Quality II
6 months ago
Lafayette, United States Southwire Company LLC Full timeA leader in technology and innovation, Southwire Company, LLC is one of North America’s largest wire and cable producers. Southwire and its subsidiaries manufacture building wire and cable, metal-clad cable, portable and electronic cord products, OEM wire products and engineered products. In addition, Southwire supplies assembled products, contractor...
-
Engineer, Quality II
4 weeks ago
Lafayette, United States Disability Solutions Full timeA leader in technology and innovation, Southwire Company, LLC is one of North America's largest wire and cable producers. Southwire and its subsidiaries manufacture building wire and cable, metal-clad cable, portable and electronic cord products, OEM wire products and engineered products. In addition, Southwire supplies assembled products, contractor...
-
Engineer, Quality II
5 months ago
Lafayette, United States Southwire Company, LLC Full timeA leader in technology and innovation, Southwire Company, LLC is one of North America's largest wire and cable producers. Southwire and its subsidiaries manufacture building wire and cable, metal-clad cable, portable and electronic cord products, OEM wire products and engineered products. In addition, Southwire supplies assembled products, contractor...
-
Manufacturing Engineer II
1 month ago
Lafayette, United States RFA Engineering Full timeRFA Engineering (www.rfamec.com) is an engineering service provider dedicated to delivering our clients with timely engineering support and expertise. We are seeking an entry-level to experienced candidate to become an integral part of our engineering team. The selected candidate will work with an experienced engineering staff using state-of-the-art...
-
Engineer, Electrical II
22 hours ago
Lafayette, United States Disability Solutions Full timeA leader in technology and innovation, Southwire Company, LLC is one of North America's largest wire and cable producers. Southwire and its subsidiaries manufacture building wire and cable, utility products, metal-clad cable, portable and electronic cord products, OEM wire products and engineered products. In addition, Southwire supplies assembled products,...
-
Engineer, Electrical II
4 weeks ago
Lafayette, United States Disability Solutions Full timeA leader in technology and innovation, Southwire Company, LLC is one of North America's largest wire and cable producers. Southwire and its subsidiaries manufacture building wire and cable, utility products, metal-clad cable, portable and electronic cord products, OEM wire products and engineered products. In addition, Southwire supplies assembled products,...
-
Field Engineer II
4 months ago
Lafayette, LA, United States Core Group Resources Full timeCore Group Resources is America's leading recruitment company. Founded by a service academy graduate who has offshore experience, Core Group Resources' expertise is unmatched in the marine offshore market, finance, IT, renewables, & non-profit for executive search, staffing, and expertise identification.Field Engineer II Job Summary We are seeking a Field...
-
Product Quality Manager
2 weeks ago
Lafayette, Colorado, United States LanceSoft Full timeAbout the RoleWe are looking for an experienced Quality Engineer II to join our team at LanceSoft. The successful candidate will be responsible for ensuring the quality of our released products and contributing to the development of new quality standards and protocols.Key Responsibilities:Develop, modify, apply, and maintain quality standards and protocols...
-
Test Engineer II
2 months ago
Lafayette, United States Entegee Full timeJob DescriptionJob DescriptionSummary:Test Engineer II responsible for performing verification and validation (V&V) activities for software and systems in medical devices, with expertise in automation testing, defect tracking, and SW risk management.Job Requirements:BS in Engineering (Electrical Engineering, Computer Science) with 3-5 years of...
-
Sr Quality Engineer
1 month ago
Lafayette, United States ATR International Full time• The Sr Quality Engineer will be supporting a New Product Development Project as a Lead Design Quality and/or Reliability Quality Engineer. In this role, the Quality Engineer will be responsible for leading and executing on Quality Deliverables related to the Design and Development Verification aspects in collaboration with other cross functional groups...
-
Test Engineer II
5 days ago
Lafayette, United States ATR International Full timeJob Title: Test Engineer II Type: Contract -6 Months Day ShiftLocation: 250 Medtronic Dr Bldg 1, Lafayette, COPay: $35.00-$45.00/hrWe are seeking a Test Engineer II for a very important client.The test engineer will be responsible for design verification activities which include writing test protocols, executing test protocols, and writing test reports....
-
Test Engineer II
6 days ago
Lafayette, United States ATR International Full timeJob Title: Test Engineer II Type: Contract -6 Months Day ShiftLocation: 250 Medtronic Dr Bldg 1, Lafayette, COPay: $35.00-$45.00/hrWe are seeking a Test Engineer II for a very important client.The test engineer will be responsible for design verification activities which include writing test protocols, executing test protocols, and writing test reports....