Overview
On Site
Contract - W2
Contract - months contract
Skills
Project Management
Performance Management
Preventive Maintenance
SAP BASIS
Leadership
RMF
Risk Management Framework
Risk Management
Reporting
Documentation
Product Development
Test Plans
Verification And Validation
Test Methods
Collaboration
Software Security
Bill Of Materials
Design Review
Cyber Security
Backup
Design Controls
Customer Support
ISO 13485
ISO 9000
Electromechanics
Embedded Systems
Embedded Software
Process Improvement
Data Analysis
Communication
Presentations
Attention To Detail
HATS
Management
Regulatory Compliance
Microsoft Office
Adobe Acrobat
Statistics
Minitab
Business Software
Six Sigma
Artificial Intelligence
Algorithms
IaaS
Quality Assurance
Medical Devices
Computer Hardware
Software Development
Biomedicine
Electrical Engineering
Job Details
Description:
12 months contract ; May extend ;
Job Title/Role: Specialist Engineer, Quality
*Possibility of temp to hire
*Hours: 8am-5pm Pacific Time
*Hybrid Local candidate preferred. Will be working with engineers and will need to come to the office on a regular basis 3 days per week or as needed. Open to remote with some travel to site.
*8+ years of progressive Quality Engineering experience in the Medical Device industry with hands-on support for hardware and software development.
Job Description
Your Role at client
Essential Duties and Responsibilities
Main Duties and Responsibilities:
Provide Quality Engineering leadership for software and hardware product development teams. Responsible for leading design control, risk management, and other Quality Engineering activities for new product development projects.
Establish and nurture strong relationships with cross-functional product development team members to optimize success of development projects.
Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.
Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation. Responsible for quality oversight and approval of product development plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, and the software BOM; lead implementation of best practices for software quality processes.
Participate in design reviews to ensure the effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.
Support the successful transfer and hyper-care phase of design and design modifications into production / field deployment.
Provide Quality Engineering support for anomalies (e.g., software bugs, cybersecurity vulnerabilities, etc.) encountered in production and development projects. Guide triage and remediation efforts.
Secondary/Backup Duties and Responsibilities:
Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
Own the resolution and timely closure of CAPAs as they relate to the design control process.
Provide Quality Engineering support for released products, interfacing with customer support representatives and account executives as necessary.
Support other areas of the Quality System and perform other tasks as defined by Management
Qualifications
Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366.
Experience in the design, development, verification, validation, and test activities for medical device hardware and software, including electromechanical medical devices and both embedded and non- embedded software.
Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
Exceptional verbal and written communication skills and presentation skills.
Exceptional attention to detail with the proven ability to wear many hats.
Manage multiple projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.
Creative problem solver.
Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab), and other business software.
Additional Qualifications:
Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt preferred.
Experience with artificial intelligence, working within an AAMI TIR45 framework, and SaMD is preferred.
Experience supporting development of classic and artificial intelligence (AI) software algorithms and deep understanding of cloud infrastructure is preferred.
Education and Experience
8+ years of progressive Quality Engineering experience in the medical device industry with hands-on support for hardware and software development.
B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.
Physical Demands and Work Environment
Ability to work with computers in a hybrid / office environment and complete occasional physical tasks normal to that environment.
*Possibility of temp to hire
*Hours: 8am-5pm Pacific Time
*Hybrid Local candidate preferred. Will be working with engineers and will need to come to the office on a regular basis 3 days per week or as needed. Open to remote with some travel to site.
*8+ years of progressive Quality Engineering experience in the Medical Device industry with hands-on support for hardware and software development.
Job Description
Your Role at client
Essential Duties and Responsibilities
Main Duties and Responsibilities:
Provide Quality Engineering leadership for software and hardware product development teams. Responsible for leading design control, risk management, and other Quality Engineering activities for new product development projects.
Establish and nurture strong relationships with cross-functional product development team members to optimize success of development projects.
Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.
Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation. Responsible for quality oversight and approval of product development plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, and the software BOM; lead implementation of best practices for software quality processes.
Participate in design reviews to ensure the effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.
Support the successful transfer and hyper-care phase of design and design modifications into production / field deployment.
Provide Quality Engineering support for anomalies (e.g., software bugs, cybersecurity vulnerabilities, etc.) encountered in production and development projects. Guide triage and remediation efforts.
Secondary/Backup Duties and Responsibilities:
Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
Own the resolution and timely closure of CAPAs as they relate to the design control process.
Provide Quality Engineering support for released products, interfacing with customer support representatives and account executives as necessary.
Support other areas of the Quality System and perform other tasks as defined by Management
Qualifications
Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366.
Experience in the design, development, verification, validation, and test activities for medical device hardware and software, including electromechanical medical devices and both embedded and non- embedded software.
Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
Exceptional verbal and written communication skills and presentation skills.
Exceptional attention to detail with the proven ability to wear many hats.
Manage multiple projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.
Creative problem solver.
Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab), and other business software.
Additional Qualifications:
Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt preferred.
Experience with artificial intelligence, working within an AAMI TIR45 framework, and SaMD is preferred.
Experience supporting development of classic and artificial intelligence (AI) software algorithms and deep understanding of cloud infrastructure is preferred.
Education and Experience
8+ years of progressive Quality Engineering experience in the medical device industry with hands-on support for hardware and software development.
B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.
Physical Demands and Work Environment
Ability to work with computers in a hybrid / office environment and complete occasional physical tasks normal to that environment.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.