Principal Process Development 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.  

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 – Principal Process Development Engineer

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.

Responsibilities:

Daily work includes both sustaining and project work –complete the types of projects that remove the need for sustaining work – improving safety, quality, output and eliminating scrap.

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 Quality and Research and Development organizations to integrate new products or processes into the existing manufacturing area.

Process validation and verification work is frequently required – knowledge of Process Validation Plans, IQ, OQ, PQ, Software validation, test method validation, gage R&R, and a clear understanding of FDA’s QSR and cGMP, and a good understanding in statistics.

Skills:

Familiarity with conventional project management methods

Strong familiarity with V&V testing for new product designs

Ability to prepare project plans, specifications, and schedules for new product development

Experience with catheters, balloons, or stents device manufacturing processes and equipment

Familiar with 510K Testing for FDA approval

Project Management using MS Project

Knowledge to develop and improve manufacturing processes to pilot production level

Experience with design and process FMEA as well as Process Validation

Application of statistical and analytical methods 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)

Functional knowledge of probability & statistics, DoE

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 process. Product development and the successful transfers into manufacturing

Proficiency in SolidWorks

Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required

Equipment and tooling design

Comfortable working independently and cross-functionally as part of a team

20% European International travel required

Requirements:

Four-year degree required, preferably in Engineering.

Minimum 7 years of experiences in position of increasing responsibility in Operations, NPI Engineering, or R&D Engineering

Class III, IIb Implantable Medical Device Experience

Typical experience required is 6+ years as an Engineer in a related field.

Deep process validation knowledge and medical device or pharmaceutical experience is required.

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 Statgraphics 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.

More information please go to www.baltgroup.com 

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