Quality Engineer II

Irvine, California, United States

About Balt  

Our purpose is to improve the lives of 150,000 patients in 2026.  

 Our story 

Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices.  Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting. 

We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.

We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives. 

 Why Join Balt? Join a passionate team, dedicated to making a difference.  

  1. Working at Balt means giving meaning to your work! Pride is a strong part of our identity.  
  2. We are a close-knit team, with strong mission, vision and values that guide our day-to-day.  
  3. Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.  
  4. No matter the country, we take care of you.  

Would you like to be part of our story? Don't hesitate, come and join us! 

 About this opportunity – Quality Engineer II

Description

The Operations Quality Engineer II will be responsible for supporting production quality and the transfer of neurovascular products to the production environment.  This engineer will be expected to work directly with production while being provided moderate levels of support/guidance from Senior level engineers and their Manager to complete tasks. This position will have the responsibility to support and continuously improve current manufacturing processes through technical and process innovation for the manufacture of neurovascular medical devices that save patient lives.

Job Responsibilities

Daily tasks:

  • Production support of existing products and processes and sustaining work
  • Support the manufacturing organization to facilitate efficient operations, optimize existing processes, and ensure that production goals are met.
  • Monitor performance of equipment/tools and work with Manufacturing Engineering to correct equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues.
  • Analyzes nonconforming product, process, and material issues supported by use of root cause tools to drive corrective actions.
  • Own NCMR and CAPA investigations and corrections/corrective actions
  • Spend significant portions of time in the production environment.
  • Work closely with production operators and Quality Control inspectors in the production environment.
  • Provide feedback to Quality, Operations, Engineering and R&D on quality issues.
  • Detail oriented review and approval documentation in support of production and process improvement

Additional Tasks:

  • Development project work – design transfer, commercialization of new products, and site manufacturing transfers
  • Interface with New Product Development team in design control projects to integrate new products or processes into the existing manufacturing area.
  • Process development, validation and verification work is required – knowledge of Process Validation Plans, IQ, OQ, PQ, software validation, test method validation/gage R&R, a clear understanding of FDA’s QMSR and cGMP, and a good understanding in the application of statistics to process analysis and improvement.
  • Communicate with suppliers to address quality concerns and resolves issues.
  • Maintain and develop processes and procedures by writing standard work instructions for operations involved with production and quality.

 

Qualification Requirements

  • Bachelor’s degree required, preferably in engineering or science discipline.
  • 2+ years as an Engineer in a related field.
  • Medical device or pharmaceutical experience.
  • Process and Equipment qualification knowledge.
  • Statistical analysis skill set.

Highly Desired Qualifications

  • Class II and III implantable medical device experience with focus on neurovascular devices.
  • Experience creating and implementing new production line layouts.
  • Minitab proficiency.
  • Strong background in medical device components using metals, plastics, extrusion, and/or adhesives.
  • A demonstrated ability to plan and run projects.

 

Skills

Required:

  • Keen attention to detail when reviewing documentation and processes.
  • Solid technical writing ability
  • Comfortable working independently and cross-functionally as part of a team.
  • Comfortable communicating with a wide range of people (production, regulatory, management, suppliers, and others)
  • General understanding of Risk Management, including design, use, and process FMEAs as well as a basic understanding of Severity, Occurrence, and Risk Mitigation and their impact on product/process controls.
  • General understanding of Process Validation (OQ/PQ) and ability to develop test protocols/report to meet FDA and ISO requirements for class II and class III devices.
  • General understanding of CAPA process and root cause analysis tools and how to use them
  • Ability to develop/draft manufacturing documentation (Manufacturing Procedures, Engineering Drawings, BOM, Work Orders).
  • General familiarity with design control requirements and V&V testing for new product designs.
  • Effectiveness with lab equipment, assembly tools, and measurement devices.
  • Basic understanding of statistical analysis techniques for identifying process capability and equivalence testing.
  • Development and qualification of tooling/ equipment (IQ/OQ, support, design).
  • Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required.

Highly Desired Qualifications:

  • Experience with catheters, coils, or stents device manufacturing processes and equipment.
  • Test Method Validation and/or Measurement System Analysis experience, including Gage R&Rs and Attribute Agreement analysis
  • Process background (development, capability, optimization, validation) within the medical device industry.
  • Equipment and tooling design and optimization using DFM and Six Sigma principles.
  • Leading project teams tasked with new product/process development and the successful transfer into manufacturing.
  • Knowledge to develop and improve manufacturing processes from concept to commercialization including characterization, validation and cost/capacity analysis.
  • Application of statistical and analytical methods for process development, optimization and control such as SPC, SQC, and DOE.
  • Knowledge of SolidWorks for both part and fixturing/equipment design.

 

Work Environment

  • Working conditions are normal for an office environment.
  • Extended computer usage.
  • Standard PPE gowning requirement for cleanroom activities is required.
  • Moderate lifting
  • Extended periods of walking or standing
  • Microscope usage

The above information on this description have been designed to indicate the general nature of work performed by employees within this position. It is not a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

 

Balt Group is an Equal Employment Opportunity employer.

 

 

\More information please go to www.baltgroup.com 

 

 

Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company’s log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt’s job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases.

 

#LI-FW1

 

Pay Range

$85,000 - $95,000 USD

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