Validation Engineer II
Carlsbad, CA · On-site
Demonstrated organizational and time-management skills to support cross-functional project ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
60 Alphatec Spine Project Manager Jobs Hiring Near You
Validation Engineer II
Carlsbad, CA · On-site
Demonstrated organizational and time-management skills to support cross-functional project ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Validation Engineer II
Carlsbad, CA · On-site
Demonstrated organizational and time-management skills to support cross-functional project ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Validation Engineer II
Carlsbad, CA · On-site
Demonstrated organizational and time-management skills to support cross-functional project ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Software Engineer II, Valence
Louisville, CO · On-site
$95K - $110K/yr
Develop documentation related to software development projects (design artifacts, test plans/cases ... Benefits Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Software Engineer II, Valence
Louisville, CO · On-site
$95K - $110K/yr
Develop documentation related to software development projects (design artifacts, test plans/cases ... Benefits Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Software Engineer II, Valence
$95K - $110K/yr
Develop documentation related to software development projects (design artifacts, test plans/cases ... Benefits Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Software Engineer II, Valence
$95K - $110K/yr
Develop documentation related to software development projects (design artifacts, test plans/cases ... Benefits Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Distribution Specialist
Memphis, TN · On-site
$19 - $21/hr
Document management software and ability to navigating the Internet * Possesses interpersonal and ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Distribution Specialist
Memphis, TN · On-site
$19 - $21/hr
Document management software and ability to navigating the Internet * Possesses interpersonal and ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Distribution Specialist
Memphis, TN · On-site
$19 - $21/hr
Document management software and ability to navigating the Internet * Possesses interpersonal and ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Quick apply
Distribution Specialist
Memphis, TN · On-site
$19 - $21/hr
Document management software and ability to navigating the Internet * Possesses interpersonal and ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Clinical Data Specialist II
Carlsbad, NM · On-site
$85K - $98K/yr
Data Management * Contribute to the development and refinement of protocol-specific cases report ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Clinical Data Specialist II
Carlsbad, NM · On-site
$85K - $98K/yr
Data Management * Contribute to the development and refinement of protocol-specific cases report ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
... managing and monitoring the sales order process * Maintains account records and report activities and submits as required by the Company. * Follows Alphatec training and procedures requirements ...
... managing and monitoring the sales order process * Maintains account records and report activities and submits as required by the Company. * Follows Alphatec training and procedures requirements ...
Systems Analyst- PLM/QMS
Carlsbad, CA · On-site
$110K - $125K/yr
Manage and support ECO, MCO, CR, Deviations, and other change workflows. * Ensure accurate routing ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Systems Analyst- PLM/QMS
Carlsbad, CA · On-site
$110K - $125K/yr
Manage and support ECO, MCO, CR, Deviations, and other change workflows. * Ensure accurate routing ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Manage multiple tasks/projects and priorities * Mentor the Junior resources and take the ownership ... Benefits Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Manage multiple tasks/projects and priorities * Mentor the Junior resources and take the ownership ... Benefits Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Manage multiple tasks/projects and priorities * Mentor the Junior resources and take the ownership ... Benefits Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Manage multiple tasks/projects and priorities * Mentor the Junior resources and take the ownership ... Benefits Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Technical leadership in development of intra-op spine navigation applications, including software ... Manage multiple tasks/projects and priorities * Mentor the Junior resources and take the ownership ...
Technical leadership in development of intra-op spine navigation applications, including software ... Manage multiple tasks/projects and priorities * Mentor the Junior resources and take the ownership ...
The 3D modeling technician is responsible for performing spine 3D modeling and alignment ... Manager
The 3D modeling technician is responsible for performing spine 3D modeling and alignment ... Manager
Quality Engineer
$74K - $96K/yr
... spinal surgery devices through compliance with regulatory, contractual, and quality system ... Manage multiple concurrent major and minor projects. * Support Design Controls to ensure efficient ...
Quality Engineer
$74K - $96K/yr
... spinal surgery devices through compliance with regulatory, contractual, and quality system ... Manage multiple concurrent major and minor projects. * Support Design Controls to ensure efficient ...
... spinal implants and instrumentation for new product development and biomechanics research. This ... projects or assignments.
... spinal implants and instrumentation for new product development and biomechanics research. This ... projects or assignments.
Manage multiple tasks/projects and priorities * Mentor the Junior resources and take the ownership ... Benefits Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Quick apply
Manage multiple tasks/projects and priorities * Mentor the Junior resources and take the ownership ... Benefits Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Manage multiple tasks/projects and priorities * Mentor the Junior resources and take the ownership ... Benefits Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Quick apply
Manage multiple tasks/projects and priorities * Mentor the Junior resources and take the ownership ... Benefits Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Contribute to the advancement of ATEC's spine surgery technologies by supporting clinical research ... Working cross-functionally, this role will lead study design and protocol execution, management and ...
Contribute to the advancement of ATEC's spine surgery technologies by supporting clinical research ... Working cross-functionally, this role will lead study design and protocol execution, management and ...
Technical leadership in development of intra-op spine navigation applications, including software ... Manage multiple tasks/projects and priorities * Mentor the Junior resources and take the ownership ...
Technical leadership in development of intra-op spine navigation applications, including software ... Manage multiple tasks/projects and priorities * Mentor the Junior resources and take the ownership ...
Quality Engineer
Carlsbad, CA · On-site
$74K - $96K/yr
Manage multiple concurrent major and minor projects. * Support Design Controls to ensure efficient ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Quick apply
Quality Engineer
Carlsbad, CA · On-site
$74K - $96K/yr
Manage multiple concurrent major and minor projects. * Support Design Controls to ensure efficient ... Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and ...
Alphatec Spine Jobs Information
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Job description
The Validation Engineer II is a mid-level role responsible for creating, planning, and executing software verification activities, and contributing to continuous improvement and validation processes. The Validation Engineer II operates under limited supervision and collaborates closely with R&D, Software Engineering, Quality Engineering, Mechanical Engineering, Marketing, and Regulatory to deliver innovative products to market in accordance with FDA, ISO, and IEC standards.
The Validation Engineer II supports a broad range of software-enabled medical devices within a product suite that includes intraoperative neuromonitoring, surgical alignment, robotic navigation, and a cloud-based end-to-end platform, among others.
The ideal candidate has experience validating software-based medical devices as well as strong technical, troubleshooting, documentation, and communication skills, and the ability to work seamlessly with cross-functional teams.
Essential Duties and Responsibilities
Requirements
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience
CERTIFICATES, LICENSES, REGISTRATIONS
ASQ CSQE or CQE preferred.
Equal Employment Opportunity & Other Disclosures
ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).
At this time, ATEC Spine does not sponsor employment visas for this position. Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.
Salary Range
Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $90,000 to $110,000 Full-Time Annual Salary
Please Note: The employer will not sponsor applicants for work visas for this position.
The Validation Engineer II supports a broad range of software-enabled medical devices within a product suite that includes intraoperative neuromonitoring, surgical alignment, robotic navigation, and a cloud-based end-to-end platform, among others.
The ideal candidate has experience validating software-based medical devices as well as strong technical, troubleshooting, documentation, and communication skills, and the ability to work seamlessly with cross-functional teams.
Essential Duties and Responsibilities
- Leads verification and validation activities for assigned projects, ensuring quality, timeline, and compliance expectations are met while working alongside cross-functional teams.
- Defines verification strategies for new product development, authoring high-quality test plans and protocols.
- Supports continuous improvement of V&V practices by identifying inefficiencies, implementing process improvements, and participating in cross-functional problem-solving.
- Creates and reviews design control documentation, ensuring requirements, test plans and protocols, test reports, and traceability meet FDA and internal quality standards.
- Designs, develops, and qualifies manual and automated system-level test methods.
- Performs validation of non-medical-device software tools and supporting systems as required, ensuring appropriate rigor and documentation.
- Supports risk management activities in accordance with ISO 14971 by contributing to hazard analysis, risk controls, and verification of risk mitigations.
- Seeks guidance from and collaborates with senior validation engineers; may informally assist with onboarding or knowledge sharing for newer team members.
- Maintains regular and consistent attendance at the primary worksite.
- Other duties as assigned.
Requirements
The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Foundational understanding of FDA Quality System Regulations (21 CFR Part 820) & ISO 13485
- Foundational understanding of IEC 62304 and IEC 60601 standards
- Foundational understanding of ISO 14971 risk management requirements
- Familiarity with defect tracking and test management tools (e.g., Jira, Polarion)
- Working knowledge of test method qualification methods (Gage R&R, Attribute Agreement Analysis) and competency using desktop lab equipment (function generators, oscilloscopes, etc.)
- Basic to working knowledge of probability and statistics concepts, and design of experiments (DoE)
- Experience supporting Design History File (DHF) documentation and Change Order routing
- Exposure to or experience supporting regulatory submissions such as 510(k)s
- Demonstrated organizational and time-management skills to support cross-functional project activities
- Ability to communicate technical concepts effectively with internal stakeholders and cross-functional team members
- Detail-oriented, deadline-driven, and able to work collaboratively in a team environment
Education and Experience
- Bachelor's or master's degree in biomedical engineering or related field
- 2-8 years of experience in V&V or systems engineering for medical devices, or other regulated industries
CERTIFICATES, LICENSES, REGISTRATIONS
ASQ CSQE or CQE preferred.
Equal Employment Opportunity & Other Disclosures
ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).
At this time, ATEC Spine does not sponsor employment visas for this position. Candidates must be authorized to work in the United States without the need for current or future employer sponsorship.
Salary Range
Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $90,000 to $110,000 Full-Time Annual Salary
Please Note: The employer will not sponsor applicants for work visas for this position.
About Alphatec Spine
Sourced by ZipRecruiter
Industry
Medical equipment and supplies manufacturing
Company size
501 - 1,000 Employees
Headquarters location
Carlsbad, CA, US
Year founded
1990