Manufacturing Engineer

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.

• Working at Balt means giving meaning to your work! Pride is a strong part of our identity.
• We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
• Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
• 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!

Description

About this opportunity – Manufacturing Engineer II

This fast-paced position will be responsible for the support and continuously improve current manufacturing process, through technical and process innovation for the manufacture of neurovascular medical devices that save patient lives.

Job Responsibilities

• Daily work includes engineering support of existing products and processes as well as ongoing improvement activities and projects including quality, cost and efficiency improvement, and capacity increases.
• 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. Further, 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 Introduction, Quality and Research and Development organizations in NPI, R&D projects to integrate new products or processes into the existing manufacturing area.
• Development of manufacturing documentation (Manufacturing Procedures, Engineering Drawings, BOM, Work Orders)
• Characterize and define equipment functional requirements and system capabilities
• Process development, validation and verification work, including validation plan, IQ, OQ, PQ, Software validation, test method validation, gage R&R.
• Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, nonconformances, audit observations) as
• Familiarity with conventional project management methods including development of project plans and timelines using software such as MS Project.
• Work in late shift might be required.
  
  

Qualification Requirements

Bachelor’s degree in engineering or related field

• At least 1 year engineering experience in medical device manufacturing is required
• A clear understanding of FDA’s QSR and cGMP, and a good understanding in the application of statistics to process analysis, improvement and control.
• Experience in development and qualification of tooling/ equipment (IQ/ OQ/ PQ, support, design) is required.
• Process development, improvement and validation experience in medical device or pharmaceutical industry.
• Experience using SolidWorks to design part and fixturing/equipment is required.
• Experience in metals, plastics, extrusion, and/or adhesives is highly desired.
• Experience with coils, catheters, balloons, or stents device manufacturing processes and equipment is highly desired.
• Experience with design and process FMEA as well as translating the associated risk analysis to Process Validation and process control requirements.
  
  

Skills:

• Effectiveness with lab equipment, assembly tools and measurement devices.
• A demonstrated ability to prepare project plans, develop specifications, and execute project plans per schedule.
• Skills to perform routine analysis of test results in relation to design specifications and test objectives.
• Statistical analysis skill set is required.
• Knowledge in Lean Six Sigma is highly desired.
• Understanding of capacity and cost analysis and modeling is highly desired.
• SolidWorks, and Minitab proficiency are highly desired.
• Proficient in Microsoft Word, Excel, PowerPoint, Project, Visio or similar applications is required.
• Comfortable working independently and cross-functionally as part of a team
• Ability to clearly communicate with team members and other members within the organization.
• Ability to handle ambiguity within tasks/direction and determine solutions for successful execution
  
  

Work Environment

Working conditions are normal for an office environment.

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

Warning: There are job offer scams impersonating companies like Balt Group. Legitimate correspondence will only come from "@baltgroup.com" emails.

Pay Range

$90,000—$100,000 USD