Senior Quality Engineer

3 weeks ago

Irvine, California, United States Balt Full time

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 – Sr Quality Engineer

Description

This fast-paced position will be responsible for sustaining production quality and the transfer of neurovascular products. You 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 work includes both sustaining and development project work – design transfer and commercialization of new products, site manufacturing transfers and support of existing products and processes.
  • Provide support to the manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met especially as it pertains with new products being introduced/transferred into manufacturing. Furthermore, monitor performance of equipment, machines and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
  • 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 frequently required – knowledge of Process Validation Plans, IQ, OQ, PQ, software validation, test method validation, gage R&R, a clear understanding of FDA's QSR and cGMP, and a good understanding in the application of statistics to process analysis and improvement.
  • Familiarity with conventional project management methods including development of project plans and timelines using applicable software.
  • Analyzes nonconforming product, process, and material issues supported by use of root cause tools to drive corrective actions.
  • Lead investigation and complete corrective actions for CAPA.
  • Manage processing of internal NCMRs, inclusive of investigation disposition, and process corrections and participate in MRB.
  • 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.
  • Maintain confidential company and supplier information.
  • Work with production operators and QC inspectors in the production environment.
  • Provide feedback to Quality, Operations, Engineering and R&D on quality issues.

Qualification Requirements

  • Bachelor's degree required, preferably in engineering or science discipline.
  • Class II and III implantable medical device experience with focus on neurovascular devices a plus.
  • Typical experience required is 5+ years as an Engineer in a related field.
  • Deep process validation knowledge and medical device or pharmaceutical experience is required.
  • Experience creating and implementing new production line layouts.
  • Equipment qualification.
  • Statistical analysis skill set is required.
  • Minitab proficiency is highly desired.
  • Strong background in medical device components using metals, plastics, extrusion, and/or adhesives is highly desired.
  • A demonstrated ability to plan and run projects is highly desired.

Skills

  • Strong familiarity with design control requirements and V&V testing for new product designs.
  • Ability to prepare project plans, specifications, and schedules for new product development.
  • Experience with catheters, coils, or stents device manufacturing processes and equipment.
  • Ability to develop test plans to meet FDA and ISO requirements for class II and class III devices.
  • Knowledge to develop and improve manufacturing processes from concept to commercialization including characterization, validation and cost/capacity analysis.
  • Experience with design and process FMEA as well as translating the associated risk analysis to Process Validation and process control requirements.
  • Application of statistical and analytical methods for process development, optimization and control such as SPC, SQC, and DOE.
  • Process background (development, capability, optimization, validation) within the medical device industry.
  • Development of manufacturing documentation (Manufacturing Procedures, Engineering Drawings, BOM, Work Orders).
  • Effectiveness with lab equipment, assembly tools and measurement devices.
  • Skills to perform routine analysis of test results in relation to design specifications and test objectives.
  • Initiate, design and execute experiments to characterize process variation and control.
  • Characterize and define equipment functional requirements and system capabilities.
  • Development and qualification of tooling/ equipment (IQ/ OQ/ PQ, support, design).
  • Leading project teams tasked with new product/process development and the successful transfer into manufacturing.
  • Knowledge of SolidWorks for both part and fixturing/equipment design.
  • Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required.
  • Equipment and tooling design and optimization using DFM and Six Sigma principles.
  • Comfortable working independently and cross-functionally as part of a team.

Work Environment

  • Working conditions are normal for an office environment.
  • Standard PPE gowning requirement for cleanroom activities is required.
  • 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.

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