Validation Engineer III
Alphatec Spine
Quality Engineer II
Alphatec Spine
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $91,000 - $108,000 per year
Job Level
JuniorMid-Level
About the role
- Mechanical Quality Engineer supporting new product development; develop, improve, and implement quality methods and systems in a regulated environment.
- Support New Product Development as primary QE for mechanical implants and instruments; manage multiple concurrent major and minor projects.
- Support Design Controls to ensure efficient, effective, and compliant new product launches.
- Support qualification of legal manufacturers (OEM) for distributed products and act as liaison/technical interface with contract manufacturers.
- Lead Material Review Board (MRB), own Non-Conformance (NC) development and resolution, lead reworks and deviations, participate in Supplier Review Board (SRB).
- Develop inspection plans and custom gauging based upon required measurement and tolerances.
- Support Change Order review for drawings considering Design for Manufacturing (DFM) and Design for Inspection (DFI).
- Support cleaning and sterilization validations of implantable devices; understand tests such as bioburden, BET, and dose audit testing.
- Support validation (IQ, OQ, and PQ) development and execution internally and at suppliers; lead supplier part qualification including PQs, GR&R, first articles, and process development.
- Apply statistical techniques to analyze manufacturing processes and recommend appropriate process controls.
- Support Risk Management efforts per ISO 14971; conduct preliminary risk assessments and support FMEA for designs and processes.
- Support Field Retrieval Assessment (FRA), Health Hazard Evaluation (HHE), MDSAP, FDA, ISO, and other regulatory audits.
- Own Supplier Corrective Actions (SCARs) and Corrective and Preventive Actions (CAPAs).
Requirements
- Good understanding of the FDA Quality System Regulations (21 CFR Part 820), ISO 13485, MDSAP, and ISO 19227.
- Direct experience with implantable devices, instrumentation, and disposables in a regulated environment.
- Knowledge of mechanical inspection methods and equipment.
- Knowledge of SPC, DOE, probability, and statistics.
- Ability to read, analyze, and interpret blueprints, including GD&T.
- Ability to solve complex problems to root cause and prevent re-occurrence (CAPA).
- Ability to process data, interpret data trends, and make basic recommendations based on findings.
- Ability to troubleshoot and manage priorities across multiple projects based upon ATEC business priorities.
- Strong technical writing skills, including ability to write protocols, reports, and procedures.
- Ability to effectively interact with all levels of the organization.
- Shows desire and ability to take on small leadership roles within projects, effective communication and collaboration with team members.
- Ability to develop and maintain strong working relationships with internal and external customers and suppliers.
- Excellent verbal and written communication, ability to resolve minor conflicts, collaborative teamwork.
- Demonstrates tenacity in overcoming obstacles; proactive in taking initiative.
- Knowledge of SolidWorks or other CAD software preferred.
- Manufacturing Engineering experience preferred, including knowledge of metal and plastic part production and processing. Process knowledge including milling, turning, EDM, 3D printing, and secondary processing.
- Detail oriented.
- Good decision-making skills and judgment.
- Ability to develop plans and strategies and execute to completion.
- Must be able to travel up to 5% of the time.
- Minimum Bachelor’s degree (BS) from a four-year college or university, preferably in Mechanical, Industrial, Biomedical, or Manufacturing Engineering.
- 2+ years related experience and/ or training; or equivalent combination of education and experience.
- 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).
