Senior 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 – Senior Process Development Engineer

Senior Process Development Engineer (Balt USA LLC, Irvine, CA): As member of team responsible for the transfer of neurovascular products, will develop new processes and support and continuously improve current manufacturing processes through technical and process innovation for the manufacture of neurovascular medical devices that save patient lives.

Specific responsibilities will include:

·         Partner with R&D Engineering to ensure Design for Manufacturing (DFM). Design and implement production systems and develop processes that are efficient and cost effective. Confer with research and biomanufacturing organizations to ensure the compatibility of design and production.

·         Work across functions, sites, contractors, and vendors to ensure that components and materials are procured per validation and initial commercial needs.

·         Prepare project plans for equipment improvements including timelines and budgetary estimates.

·         Create all required documentation which includes but is not limited to manufacturing process procedures, protocols, and testing reports.

·         Develop and qualify in process test methods.

·         Plan, implement, and test production systems and processes and ensure compliance with industry and regulatory standards.

·         Plan and coordinate the execution of process characterization and validation.

·         Ensure process capability and yield targets are met.

·         Successfully complete all process development engineering elements of the Product Development Process (PDP) by due date.

·         Partner with manufacturing engineering and production to ensure set up, training and all other product transfer activities are successfully executed for new product lines.

·         Support the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes, and to ensure that production goals are met.

·         Review existing manufacturing processes to identify opportunities for yield improvement or reduced process variation.

·         Ensure proper tooling, fixturing, and equipment are developed, procured, and qualified per quality requirements.

·         Monitor performance of equipment, machines, and tools and correct 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.

·         Develop statistical models or simulations using statistical or modeling software.

·         Use Minitab or other software to perform data analysis.

·         Maintain databases of experiment characteristics and/or results.

·         Validate and verify processes.

·         Improve safety, quality, output and eliminate scrap.

·         Communicate with regulatory authorities regarding compliance responsibilities.

·         Read current scientific or trade literature to stay abreast of scientific, industry, and/or technology advances.

·         Mentor junior engineers and technicians.

 Minimum Requirements: Bachelor’s degree in Biomedical Engineering or related engineering field of study and 4 years of experience working in process within the medical device industry with Class III, IIb implantable medical devices.

Must also have: (I) Knowledge of Process Validation Plans, IQ, OQ, PQ, software validation, test method validation, and gage R&R; (II) Thorough understanding of FDA’s QSR and cGMP; (III) Background in Statistics, specifically in statistical and analytical methods including SPC, SQC, and DOE; (IV) Background with catheters, balloons, and/or stents device manufacturing processes and equipment; (V) Background using software including Solidworks, ProE, Minitab, Microsoft project, and Smartsheet; (VI) Excellent communication, social and presentation skills with meticulous attention to detail.

More information please go to www.baltgroup.com 

Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company’s log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt’s job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases.

#LI-FW1