Are you inspired by a fast-paced, innovative environment that will challenge you to find creative solutions? At Balt, we foster a culture of collaboration that drives constant innovation. Our goal is to enhance the care of patients with neurovascular disease through physician-inspired innovative solutions. Balt’s 40 year legacy of bringing first-to-market products is now in the US. We are looking for dedicated, creative and collaborative individuals to join us in building the next great neurovascular device company. If this sounds like you, please select from our open positions below.

Quality Engineering Technician

Are you looking for a career that makes a difference in people’s lives? We are expanding our team and encourage you to consider a career at Balt. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine.  As a team member of Balt, you will have an impact on the continued evolution of Balt: from its history as a niche R&D company in Europe to a global neurovascular device company.

The Quality Engineering Technician is responsible for supporting complaint analysis, root cause investigations, device testing, and process validations as directed by the Quality Engineering team.

You are responsible for (but not limited to):

  • Cleaning and disinfection of lab spaces.
  • Decontamination and documentation of complaint samples received in the lab for evaluation purposes.
  • Conduct complaint investigations as defined per standard work instructions.
  • Collect, record, and analyze sample analysis data accurately.
  • Maintain good documentation practices when recording all data.
  • Maintain good laboratory practices consistent with biosafety laboratory practices.
  • Maintains a clean and safe lab work environment.
  • Storage and disposal of complaint samples in accordance with applicable procedures.
  • Use calibrated laboratory equipment and tools.
  • Assist in the development and implementation of Gage R&R and capability studies
  • Execute testing defined per IQ, OQ, and PQ protocols.
  • Assist the investigation, root cause analysis, and corrective action activities to support NCR’s, CAPA system, and Customer Complaints.
  • Execute testing required to validate new test methods to support design verification, design validation, or process validation.
  • Identify and escalate all unexpected analysis results to Quality Engineering.

To Succeed in this role, you should have the following skills and qualifications:

  • Basic problem-solving / troubleshooting and math skills.
  • Clear and effective verbal and written communication skills
  • Perform device assessment and testing per standard operating procedures.
  • Microsoft Word, Excel, and Outlook.
  • Minimum 3 years of relevant medical device industry experience.
  • Experience using a variety of test equipment, inspection tools, biosafety, and good laboratory practices.
  • Education: High School Diploma or Associate degree in technical studies

BALT is a world leader in the design and manufacture of interventional neuroradiology devices to treat neurovascular pathologies (strokes, aneurysms, AVMs). By placing innovation at the center of its model, the company maintains its leading position in the neuroradiology field worldwide.  We are growing our company worldwide with a focus on the commercialization of Balt products in the United States as well as continuing a tradition of physician inspired innovation through novel research and development.

Diverse workforces create the best culture, company, and products!  We at Balt are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Balt does not discriminate based on sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Quality Engineer I

Are you looking for a career that makes a difference in people’s lives? We are expanding our team and encourage you to consider a career at Balt. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine.  As a team member of Balt, you will have an impact on the continued evolution of Balt: from its history as a niche R&D company in Europe to a global neurovascular device company.

The Quality Engineer I develop, implements, and maintains procedures for compliance to regulatory requirements, internal procedures, inspection & sampling documents. Develops and implements systems to improve the detection and prevention of quality failures.  Process improvements; analyzes nonconforming product/process/material issues. Supports Manufacturing/Ops transfer activities, including equipment and process qualifications/validations. Participates in Quality planning- facilities and products:  requirements, documentation and completion (overview/monitoring).

You are responsible for (but not limited to):

  • Perform quality inspections according to written procedures.
  • Assist in the development of new inspection and test methods.
  • Provide feedback to QA, Operations and R&D on quality issues.
  • Assist product development team members in initiating document changes.
  • Integral part of project team to launch new products.
  • Integral part of project team for manufacturing transfer activities, equipment and cleanroom qualifications.

To Succeed in this role, you should have the following skills and qualifications:

  • Inspection techniques, including technical documentation and mechanical drawings.
  • Knowledge of Quality Systems for medical device manufacturing and requirements for inspection and testing.
  • Plans, documents (protocol and reporting) product/process validations.
  • Contract review-new customer/new product.
  • Participate in supplier qualification activities and audits.
  • Initiates and/or verifies corrective and preventative actions resulting from NCMR’s, audit findings and customer complaints.
  • Develops and completes qualifications for manufacturing transfer activities, including new or changed materials and processes, equipment IQ/OQ/PQ/PPQ, etc.
  • Identify/evaluate quality inspection/test equipment requirements.
  • Lead Quality Circles for process improvement/problem solving.
  • Degree in related field or equivalent.
  • 0-2 years in quality control for medical device manufacturing.
  • Use of video inspection equipment (desirable) and other inspection tools.
  • Inspection sampling plans.

BALT is a world leader in the design and manufacture of interventional neuroradiology devices to treat neurovascular pathologies (strokes, aneurysms, AVMs). By placing innovation at the center of its model, the company maintains its leading position in the neuroradiology field worldwide.  We are growing our company worldwide with a focus on the commercialization of Balt products in the United States as well as continuing a tradition of physician inspired innovation through novel research and development.

 

Diverse workforces create the best culture, company, and products!  We at Balt are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Balt does not discriminate based on sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Global Labeling Manager

Are you looking for a career that makes a difference in people’s lives? We are expanding our team and encourage you to consider a career at Balt. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine.  As a team member of Balt, you will have an impact on the continued evolution of Balt: from its history as a niche R&D company in Europe to a global neurovascular device company.

The Global Labeling Manager is responsible for planning, organizing, developing, and implementation of all activities within the labeling function. This role will also support all labeling for current commercialized products and new product development. The individual in this role will identify opportunities for new labeling concepts, materials, process, and systems.

You are responsible for (but not limited to):

  • Directly manages the labeling team. Provides coaching, mentoring, and effective oversight of the team.
  • Identify and leverage opportunities to drive improved label process (e.g., culture, training, processes, tools, standards, etc.).
  • Leads and ensures cross-functional collaboration to comply with labeling procedures and external global regulatory standards in an effective and efficient manner.
  • Sets expectations of key suppliers related to printed labels, translations, and IFU printing.
  • Manages the end-to-end labeling process to minimize the risk to patients of a significant error occurring in final labeling preparations that results in a product delay or recall due to labeling.
  • Development of SOPs (Standard Operating Procedures) for Labeling, UDI and EUDAMED in compliance with the internal and key external global regulatory requirements including EU MDR.
  • Identifying and communicating quality or compliance risks associated with product labeling and determination of appropriate plan to address risks.
  • Participating and/or overseeing the disposition of product labeling and finished good
  • Responsible for labeling design reviews as needed.

To Succeed in this role, you should have the following skills and qualifications:

  • Attention to detail, document management, and strong project management skills.
  • Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.
  • Demonstrated ability to work effectively and build cross-functional relationships with internal and external personnel.
  • Strong analytical thinking, questioning & problem-solving skills.
  • Microsoft Word, Excel, PowerPoint, and Outlook.
  • Minimum 5 years’ experience with developing artwork and graphics for FDA regulated medical device or drug products. Creation and management of labeling design changes.
  • Minimum 3 years’ experience in a managerial role with direct reports.
  • Knowledge and understanding of FDA and ISO medical device labeling regulations.
  • Experience utilizing label design software such as Easy Label, NiceLabel, Bartender, or Adobe Illustrator/Photoshop and other related software
  • Education: Bachelor’s degree in a technical or business management area.

BALT is a world leader in the design and manufacture of interventional neuroradiology devices to treat neurovascular pathologies (strokes, aneurysms, AVMs). By placing innovation at the center of its model, the company maintains its leading position in the neuroradiology field worldwide.  We are growing our company worldwide with a focus on the commercialization of Balt products in the United States as well as continuing a tradition of physician inspired innovation through novel research and development.

Diverse workforces create the best culture, company, and products!  We at Balt are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Balt does not discriminate based on sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.