Test Method Validation Engineer
Job Location:
West Valley City, UT - USA
Yearly Salary:
Posted on:
Vacancies:
Job Summary
About Scientia Vascular:
Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.
Quality Engineer Role:
This position assures that new product designs and the processes for manufacturing them meet all requirements with respect to safety and efficacy. This individual will be active on new product development and ongoing manufacturing activities. This role will prioritize a focus on test method development measurement system analysis and test method validation.
Primary Responsibilities:
- Develop or assist in development of inspection and test methods per product specifications.
- Provide Technical guidance to Quality Engineers Quality Technicians and Inspectors.
- Development of Test Protocols and Final Report to support Regulatory 510K PMA CE mark and international registrations.
- Support Pre-Concept Front End Product Innovation Process activities for new technologies.
- Lead Quality Engineering Projects to improve Quality systems and Procedures.
- Assist with the development of the Design Validation Protocol and the subsequent Design Validation Report including an analysis of all data and a decision on design acceptability.
- Provide input into the project Failure Modes and Effects Analysis Device Master Record Risk Analysis Risk Benefit Risk Management Plan and Risk Management Report for the product development process.
- Determine the degree of Biocompatibility testing required as per ISO10993 and company -ordinate the testing at an outside lab and document results.
- Assist in the development test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating.
- Design and qualify inspection test methods and equipment.
- Develop and document the Quality Management System for the manufacture of new products including Inspection Plans for the inspection of components sub-assemblies and final product.
- Support the development of FMEAs.
- Perform and/or Support Process Development Studies to determine the acceptability of new processes or equipment.
- Support Process Transfers to the Production facilities.
- Conduct investigations of rejected nonconforming components and products; conduct NCR action when required.
- Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality Engineering.
- Provide technical support to resolve quality problems in development pilot manufacturing or with suppliers as warranted.
- Other duties as assigned with or without accommodation.
Requirements:
- Bachelors or Master of Science Degree in Engineering or Technical Sciences or equivalent work experience and/or professional qualifications.
- Experience with Quality in a manufacturing environment.
- Knowledge and experience with advanced quality systems concepts regulatory compliance requirements and applied statistical concepts.
- Demonstrated knowledge of interpretation and application of QSR MDD ISO 13485 and other international standards.
- Good oral and written communication skills
Preferences:
- Demonstrated experience and success in test method development and validation
- 3-7 years of industry experience
Key benefits we provide:
- Medical Dental Vision insurance
- Generous Paid Time Off (PTO)
- Paid Parental Leave
- Paid Holidays
- 401k Plan (with a generous employer match)
- Life Insurance (company paid)
- Short-Term & Long-Term Disability Insurance (company paid)
- Subscription to
- Employee Assistance Program
- An environment of belonging where everyone can thrive
Commitment to Equal Opportunity:
The Scientia Vascular culture is centered on the principals of equal opportunity for all employees. Consistent with our culture all qualified applicants will receive consideration for employment without regard to race color religion gender gender identity or expression family status marital status sexual orientation national origin genetics disability age or veteran status or any other non-merit based or legally protected grounds.
Required Experience:
IC
About Company
Welcome to the forefront of neurovascular innovation. At Scientia Vascular, we’re not just pushing boundaries; we’re redefining them. Our advanced approach to neurovascular treatment systems is key to unlocking new possibilities in healthcare. And with a track record of success and gr ... View more
