Sr Quality Engineer - Exempt - LanceSoft Inc
Lafayette, CO 80026
About the Job
Must Have:
2-5 Years Experience in Quality with BS in Engineering
• 5+ years of application testing and/or development experience with Bachelors Degree in Engineering (Computer Science, Software, Biomedical, or Electrical preferred), or 2+ years of experience with additional advanced degree.
A Bachelor degree in electrical engineering is required. One or more years’ experience in medical device product development or equivalent is required. Solid understanding of engineering fundamentals and proven hands-on electronic/mechanical skills.
conducting dFMEA
CTQ Analysis
Design Failure Mode Effective Analysis
develop CTQs
Develop DFMEA
monitoring of CTQ parameters and specifications
Nice to Have:
5+ years of application testing and/or development experience with Bachelors Degree in Engineering (Computer Science, Software, Biomedical, or Electrical preferred), or 2+ years of experience with additional advanced degree.
JOB DESCRIPTION
Here are the Deliverables that my group is responsible for and my group is (Hardware / Reliability / Design Quality Engineers)
Electrical Engineering Knowledge and Skills
Design Failure Modes and Effects Analysis (DFMEA)
Critical to Function Matrix (CTF)
Critical to Quality (CTQ)
Sub-System Requirements
Sub-System Risk Based Design Verification
Design / Technical Print Reviews
Design Verification
Reliability Plan Development
Reliability Strategy Development
Reliability Growth Testing Development
Reliability Assessments
Reliability Allocation, Modeling, and Prediction
Electrical / Thermal De-Rating
Reliability Test System Development
Reliability Testing (ALT / HALT / etc.)
Demonstrated Reliability
Electromagnetic Compatibility (EMC)
EMC Requirements and Planning
Pre-Compliance Plan / Testing
EMC Test System Development
EMC Certification
The Senior Quality Engineer position on the team supports new product development for various product families in the Surgical Innovations Business. In this role, the Quality Engineer works as part of the quality team supporting the cross-functional core team. An understanding of Conducting/Leading/Developing the Design Failure Modes and Effects Analysis, the Critical to Function Matrix, Risk Management process per ISO 14971, Design Verification Protocol and Report Development and Review, Design Validation Protocol Development and Review, Reliability Test Method Development/Setup/Analysis, Develop/Conduct Reliability studies and evaluations, Mechanical and Electro-Mechanical Design, Electrical Hardware/Design/Device Schematic and Understanding, Reliability Test Development, Electromagnetic Compatibility (EMC) Requirements/Testing/Development. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.
Top 4 technical skills that are required for the role:
Electrical Engineering Experience
Design Failure Modes and Effects Analysis Development
Critical to Quality and Critical to Function understanding from Design, Part, Component, Assembly Perspective
Reliability Test Method Development / Strategy / Statistical Analysis
Education Required: Bachelors degree in Electrical Engineering, Engineering, Science or Technical field with 4+ years of experience in Quality and/or Engineering OR Advanced Degree in Engineering, Science or Technical field with 2+ years ofexperience in Quality and/or Engineering
Years’ Experience Required: 4+ Years in Quality / Engineering
Will the contractor be working 40 hours a week? If not, weekly estimate? YES 40 hours/week
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hyrbird/Flex – Minimum 3days / week In Office, 2 Days Remote.
What is your timeline for scheduling interviews? ASAP, Immediately
What product line will this person support?
Project Horizon
Additional edits to the job description:
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 such as Research & Development, Manufacturing/Operations Engineering, and Design Engineers. The Quality Engineer Leads the Development, Facilitation, and Collaboration of Deliverables such as DFMEA (Design Failure Modes Analysis), Critical to Quality (CTQ), Critical to Function (CTF) Matrix, Component / Part Feature Criticality Development, Engineering Testing/Development, Reliability Testing and Development, Design Verification and Validation, Risk Based Design Verification and Validation, Risk Management Understanding. Additionally, The Deliverables that the Quality Engineer will be responsible for leading/supporting and executing upon include knowledge of Electrical Engineering related deliverables and design, Reliability Plan Development, Reliability Strategy Development, Reliability Growth Testing Development, Reliability Assessments, Reliability Allocation/Modeling/Prediction, Electrical / Thermal De-Rating, Reliability Test System Development, Reliability Testing (ALT / HALT / etc.), Demonstrated Reliability. The engineer will also be leading/supporting Sub-System Requirements development, Sub-System Risk Based Design Verification, need to have Design / Technical Print Reviews understanding, Electromagnetic Compatibility (EMC), EMC Requirements and Planning, Pre-Compliance Plan / Testing, EMC Test System Development, EMC Certification.
The Sr. Quality Engineer also Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with Research and Development (R&D) engineering and manufacturing functions to ensure quality standards are in place.
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Leads the Development, Facilitation, and Collaboration of Deliverables such as DFMEA (Design Failure Modes Analysis), Crtiical to Quality (CTQ), Component / Part Feature Criticality Development, Engineering Testing/Development, Design Verification and Validation, Risk Based Design Verification and Validation, Risk Management Understanding. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
2-5 Years Experience in Quality with BS in Engineering
• 5+ years of application testing and/or development experience with Bachelors Degree in Engineering (Computer Science, Software, Biomedical, or Electrical preferred), or 2+ years of experience with additional advanced degree.
A Bachelor degree in electrical engineering is required. One or more years’ experience in medical device product development or equivalent is required. Solid understanding of engineering fundamentals and proven hands-on electronic/mechanical skills.
conducting dFMEA
CTQ Analysis
Design Failure Mode Effective Analysis
develop CTQs
Develop DFMEA
monitoring of CTQ parameters and specifications
Nice to Have:
5+ years of application testing and/or development experience with Bachelors Degree in Engineering (Computer Science, Software, Biomedical, or Electrical preferred), or 2+ years of experience with additional advanced degree.
JOB DESCRIPTION
Here are the Deliverables that my group is responsible for and my group is (Hardware / Reliability / Design Quality Engineers)
Electrical Engineering Knowledge and Skills
Design Failure Modes and Effects Analysis (DFMEA)
Critical to Function Matrix (CTF)
Critical to Quality (CTQ)
Sub-System Requirements
Sub-System Risk Based Design Verification
Design / Technical Print Reviews
Design Verification
Reliability Plan Development
Reliability Strategy Development
Reliability Growth Testing Development
Reliability Assessments
Reliability Allocation, Modeling, and Prediction
Electrical / Thermal De-Rating
Reliability Test System Development
Reliability Testing (ALT / HALT / etc.)
Demonstrated Reliability
Electromagnetic Compatibility (EMC)
EMC Requirements and Planning
Pre-Compliance Plan / Testing
EMC Test System Development
EMC Certification
The Senior Quality Engineer position on the team supports new product development for various product families in the Surgical Innovations Business. In this role, the Quality Engineer works as part of the quality team supporting the cross-functional core team. An understanding of Conducting/Leading/Developing the Design Failure Modes and Effects Analysis, the Critical to Function Matrix, Risk Management process per ISO 14971, Design Verification Protocol and Report Development and Review, Design Validation Protocol Development and Review, Reliability Test Method Development/Setup/Analysis, Develop/Conduct Reliability studies and evaluations, Mechanical and Electro-Mechanical Design, Electrical Hardware/Design/Device Schematic and Understanding, Reliability Test Development, Electromagnetic Compatibility (EMC) Requirements/Testing/Development. As an important member of our Quality Team, you will provide guidance and implement strategies that drive product quality and continuous improvement.
Top 4 technical skills that are required for the role:
Electrical Engineering Experience
Design Failure Modes and Effects Analysis Development
Critical to Quality and Critical to Function understanding from Design, Part, Component, Assembly Perspective
Reliability Test Method Development / Strategy / Statistical Analysis
Education Required: Bachelors degree in Electrical Engineering, Engineering, Science or Technical field with 4+ years of experience in Quality and/or Engineering OR Advanced Degree in Engineering, Science or Technical field with 2+ years ofexperience in Quality and/or Engineering
Years’ Experience Required: 4+ Years in Quality / Engineering
Will the contractor be working 40 hours a week? If not, weekly estimate? YES 40 hours/week
Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Hyrbird/Flex – Minimum 3days / week In Office, 2 Days Remote.
What is your timeline for scheduling interviews? ASAP, Immediately
What product line will this person support?
Project Horizon
Additional edits to the job description:
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 such as Research & Development, Manufacturing/Operations Engineering, and Design Engineers. The Quality Engineer Leads the Development, Facilitation, and Collaboration of Deliverables such as DFMEA (Design Failure Modes Analysis), Critical to Quality (CTQ), Critical to Function (CTF) Matrix, Component / Part Feature Criticality Development, Engineering Testing/Development, Reliability Testing and Development, Design Verification and Validation, Risk Based Design Verification and Validation, Risk Management Understanding. Additionally, The Deliverables that the Quality Engineer will be responsible for leading/supporting and executing upon include knowledge of Electrical Engineering related deliverables and design, Reliability Plan Development, Reliability Strategy Development, Reliability Growth Testing Development, Reliability Assessments, Reliability Allocation/Modeling/Prediction, Electrical / Thermal De-Rating, Reliability Test System Development, Reliability Testing (ALT / HALT / etc.), Demonstrated Reliability. The engineer will also be leading/supporting Sub-System Requirements development, Sub-System Risk Based Design Verification, need to have Design / Technical Print Reviews understanding, Electromagnetic Compatibility (EMC), EMC Requirements and Planning, Pre-Compliance Plan / Testing, EMC Test System Development, EMC Certification.
The Sr. Quality Engineer also Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with Research and Development (R&D) engineering and manufacturing functions to ensure quality standards are in place.
Responsibilities may include the following and other duties may be assigned. Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality. Leads the Development, Facilitation, and Collaboration of Deliverables such as DFMEA (Design Failure Modes Analysis), Crtiical to Quality (CTQ), Component / Part Feature Criticality Development, Engineering Testing/Development, Design Verification and Validation, Risk Based Design Verification and Validation, Risk Management Understanding. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Source : LanceSoft Inc