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TheSr.Validation Engineeris an advancedroleresponsible forcreating, planning,and executingcomplexsoftwareverificationactivities,andcontributing tocontinuous improvement and validation processes.The Sr.ValidationEngineercollaboratesclosely withR&D, Software Engineering,Quality Engineering,Mechanical Engineering,Marketing, and Regulatorytodeliverinnovativeproductsto marketin accordance withFDA, ISO, and IEC standards.
The ideal candidate hassubstantial experiencevalidatingsoftware-based medical devices, including yearsdedicated tonavigation and robotics technology,as well asstrong technical, troubleshooting,documentation, and communication skills, andthe abilitytoworkseamlessly with cross-functional teams.
Essential Duties and Responsibilities
Leadsverification and validation activities for complex projects, ensuring quality, timeline, and compliance expectationsare met while guidingcross-functional teams.
Defines verificationstrategies for new product development, authoringhigh-qualitytest plansand protocols-particularly in areas with limited precedent or high ambiguity.
ImprovesV&V practices by introducing improved methodologies,optimizingprocesses, andfacilitatingcross-functional problem-solving to support projectobjectives.
Createsand reviews design control documentation,ensuringrequirements, test plansand protocols, testreports,andtraceabilitymeet FDA and internal quality standards.
Designs, develops, and qualifies manual and automated system-level test methods.
Performsvalidationof non–medical-device software tools and supporting systems asrequired, ensuringappropriate rigorand documentation.
Supports risk management activitiesin accordance withISO 14971.
Provides informal mentorship and technical guidance toless experiencedvalidation engineers.
Maintainsregular and consistent attendance at theprimaryworksite.
Other duties asassigned.
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.
Understanding ofFDA Quality System Regulations (21 CFR Part 820)& ISO 13485
Understanding ofIEC 62304andIEC 60601standards
Understanding ofISO 14971risk managementrequirements
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)andcompetency using desktop lab equipment (function generators, oscilloscopes, etc.)
Working knowledge ofStatistical Process Control (SPC),Design of Experiments(DOE),andprobability/statisticsconcepts
Background supporting regulatory submissions such as 510(k)s
Strong project management skills to coordinatecomplex, cross-functional projects
Ability to communicate technical concepts effectively with internal and external stakeholders, including executive management
Detail-oriented,deadline-driven, and ableto work collaboratively in a team environment
Education and Experience
Bachelor’sorMaster’sdegree inBiomedical Engineeringor related field.
8+years ofexperience inV&Vor SystemsEngineeringformedical devices,or other regulated industries.
CERTIFICATES, LICENSES, REGISTRATIONS ASQ CSQE or CQE preferred.
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).
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.
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. $130,000 to $160,000 Full-Time Annual Salary
Please Note: The employer will not sponsor applicants for work visas for this position.
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The ideal candidate hassubstantial experiencevalidatingsoftware-based medical devices, including yearsdedicated tonavigation and robotics technology,as well asstrong technical, troubleshooting,documentation, and communication skills, andthe abilitytoworkseamlessly with cross-functional teams.
Essential Duties and Responsibilities
Leadsverification and validation activities for complex projects, ensuring quality, timeline, and compliance expectationsare met while guidingcross-functional teams.
Defines verificationstrategies for new product development, authoringhigh-qualitytest plansand protocols-particularly in areas with limited precedent or high ambiguity.
ImprovesV&V practices by introducing improved methodologies,optimizingprocesses, andfacilitatingcross-functional problem-solving to support projectobjectives.
Createsand reviews design control documentation,ensuringrequirements, test plansand protocols, testreports,andtraceabilitymeet FDA and internal quality standards.
Designs, develops, and qualifies manual and automated system-level test methods.
Performsvalidationof non–medical-device software tools and supporting systems asrequired, ensuringappropriate rigorand documentation.
Supports risk management activitiesin accordance withISO 14971.
Provides informal mentorship and technical guidance toless experiencedvalidation engineers.
Maintainsregular and consistent attendance at theprimaryworksite.
Other duties asassigned.
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.
Understanding ofFDA Quality System Regulations (21 CFR Part 820)& ISO 13485
Understanding ofIEC 62304andIEC 60601standards
Understanding ofISO 14971risk managementrequirements
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)andcompetency using desktop lab equipment (function generators, oscilloscopes, etc.)
Working knowledge ofStatistical Process Control (SPC),Design of Experiments(DOE),andprobability/statisticsconcepts
Background supporting regulatory submissions such as 510(k)s
Strong project management skills to coordinatecomplex, cross-functional projects
Ability to communicate technical concepts effectively with internal and external stakeholders, including executive management
Detail-oriented,deadline-driven, and ableto work collaboratively in a team environment
Education and Experience
Bachelor’sorMaster’sdegree inBiomedical Engineeringor related field.
8+years ofexperience inV&Vor SystemsEngineeringformedical devices,or other regulated industries.
CERTIFICATES, LICENSES, REGISTRATIONS ASQ CSQE or CQE preferred.
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).
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.
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. $130,000 to $160,000 Full-Time Annual Salary
Please Note: The employer will not sponsor applicants for work visas for this position.
#J-18808-Ljbffr