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!
About this opportunity – Senior Manufacturing Engineer
Description
This fast-paced position will be responsible for 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 engineering support of existing products and processes as well as ongoing improvement activities and projects including cost and efficiency improvement, capacity increases and manufacturing line duplications between sites.
- 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 frequently using lean and six sigma techniques. 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 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 software such as MS Project.
Qualification Requirements:
- Bachelor's Degree required, preferably in Engineering.
- Class II, IIB and III Implantable Medical Device Experience
- Typical experience required is 4 years minimum 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
- Neurovascular experience is a plus
- Strong background in metals, plastics, extrusion, and/or adhesives is highly desired.
- SolidWorks, Nicelabel, and Minitab proficiency are highly desired.
- Microsoft Project, Microsoft Visio, and Microsoft Access proficiency are highly desired.
- A demonstrated ability to plan and run projects is highly desired
- 10% European International travel required
Skills:
- Ability to prepare project plans, specifications, and schedules for new product development
- Experience with catheters, balloons, or stents device manufacturing processes and equipment
- Ability to develop master validation plans to meet FDA and ISO requirements for class II and class III devices
- Knowledge to develop and improve manufacturing processes from concept to implementation 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
- Ability to use lean and six sigma tools to analyze a production line and determine and implement improvements for efficiency and capacity
- Characterize and define equipment functional requirements and system capabilities
- Development and qualification of tooling/ equipment (IQ/ OQ/ PQ, support, design)
- Proficiency in 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
- 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.
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