SciPro
Verification Validation Engineer, Medical Device
SciPro, San Francisco, California, United States, 94199
Verification Validation Engineer, Medical Device
This range is provided by SciPro. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $120,000.00/yr - $145,000.00/yr
Direct message the job poster from SciPro
VP, Client Management - SciPro, Life Science Talent Solutions *** This is not a software role***
The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons
Responsibilities
Plan, execute, and document design verification and validation (V&V) activities to support product development and ensure compliance with internal and regulatory requirements.
Technical Support
Provide engineering support for all technical aspects of the product, including instruments and systems throughout the product lifecycle.
Regulatory Compliance
Ensure product development and V&V activities align with regulatory standards (e.g., FDA QSRs, ISO 13485, ISO 14971). Support documentation and submission efforts as required.
Design Control
Participate in and support the design control process, including documentation, reviews, traceability, and compliance with quality management systems.
Assist in post-market product support, including root cause analysis and engineering evaluations to address product issues or improvements.
Quality and Compliance Authority
Exercise authority to hold any product or QA/RA documentation from shipment or further processing in the event of potential non-compliance. Escalate concerns to direct supervisor or higher management promptly.
Qualifications
3+ years of recent experience as a Verification & Validation Engineer in a fast-growing medical device company, ideally focused on specialty medical practices.
Project Management Skills: Strong planning and organizational skills, with the ability to manage schedules and meet deadlines. Shows initiative and persistence in driving tasks to completion.
Technical Writing: Clear and accurate technical writing skills, with close attention to detail.
Standards-Based Testing: Experience performing testing in accordance with industry standards such as ISO or ASTM.
Communication & Teamwork: Strong communicator who works well with engineers, surgeons, clinicians, and sales/distribution teams.
Cross-Functional Knowledge: Solid understanding of how different areas of a medical device company work together — including engineering, manufacturing, R&D, product marketing, clinical, regulatory, and quality.
Test Fixture Design: Experience designing and building mechanical test fixtures using tools like mills, lathes, or 3D printers.
Seniority Level
Associate
Employment Type
Full-time
Job Function
Medical Equipment Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Location Sunnyvale, CA
#J-18808-Ljbffr
Base pay range $120,000.00/yr - $145,000.00/yr
Direct message the job poster from SciPro
VP, Client Management - SciPro, Life Science Talent Solutions *** This is not a software role***
The focus will be mechanical / medical device testing and V&V protocols through simulated use studies in partnership with surgeons
Responsibilities
Plan, execute, and document design verification and validation (V&V) activities to support product development and ensure compliance with internal and regulatory requirements.
Technical Support
Provide engineering support for all technical aspects of the product, including instruments and systems throughout the product lifecycle.
Regulatory Compliance
Ensure product development and V&V activities align with regulatory standards (e.g., FDA QSRs, ISO 13485, ISO 14971). Support documentation and submission efforts as required.
Design Control
Participate in and support the design control process, including documentation, reviews, traceability, and compliance with quality management systems.
Assist in post-market product support, including root cause analysis and engineering evaluations to address product issues or improvements.
Quality and Compliance Authority
Exercise authority to hold any product or QA/RA documentation from shipment or further processing in the event of potential non-compliance. Escalate concerns to direct supervisor or higher management promptly.
Qualifications
3+ years of recent experience as a Verification & Validation Engineer in a fast-growing medical device company, ideally focused on specialty medical practices.
Project Management Skills: Strong planning and organizational skills, with the ability to manage schedules and meet deadlines. Shows initiative and persistence in driving tasks to completion.
Technical Writing: Clear and accurate technical writing skills, with close attention to detail.
Standards-Based Testing: Experience performing testing in accordance with industry standards such as ISO or ASTM.
Communication & Teamwork: Strong communicator who works well with engineers, surgeons, clinicians, and sales/distribution teams.
Cross-Functional Knowledge: Solid understanding of how different areas of a medical device company work together — including engineering, manufacturing, R&D, product marketing, clinical, regulatory, and quality.
Test Fixture Design: Experience designing and building mechanical test fixtures using tools like mills, lathes, or 3D printers.
Seniority Level
Associate
Employment Type
Full-time
Job Function
Medical Equipment Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
Location Sunnyvale, CA
#J-18808-Ljbffr