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.
Sr. Process Development Engineer
The Senior Process Development Engineer reports to the Director of Manufacturing and drives process and equipment solutions used in Class II and III neurovascular medical device manufacturing. A need exists to transfer many remarkable products from our European parent facility to our Irvine facility in support of a worldwide capacity expansion. These products present an overwhelming opportunity to take a defined product, develop new processes and equipment around existing specifications, perform all necessary testing required, and setup a pilot line in the Irvine facility. The Senior Process Development Engineer will define, map out, and execute the respective project plan necessary to execute within a respective timeline.
The Senior Process Development Engineer will be responsible for the development & optimization of new manufacturing concepts and technologies. This individual will provide solutions to complex technical problems associated with processes and equipment using problem solving techniques and methodologies. The engineer will be involved in process innovation with emphasis on improving quality, reducing process variation, reducing cycle time and cost down initiatives. Further, this individual will actively participate in the transfer of revolutionary products from our European facility to our Irvine location with the creation of robust and capable processes, ensuring R&D and Operations needs and targets are incorporated into the plans and activities. This team member will utilize certain development techniques such as Design for Manufacturing and Lean Six Sigma.
We are looking for a qualified person in an Engineering discipline and desirably with at least 5-10 years of medical device experience in a comparable role. A dynamic team player that can work effectively and proactively on cross-functional, cross-site teams with a good understanding of the product and process development process. Good organizational, presentation and project management skills are a must. Must be a good communicator at all levels and all functions in the organization fluent in English, both in writing and speaking.
Responsibilities will include:
- 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
Sr. Process Development Technician
The Sr. Process Development Technician is one who possesses a unique talent for communicating and learning new technologies and procedures, has excellent creative skills and is motivated to complete jobs on short timelines corresponding with changes in task lists and priorities. This position requires a strong technical background and knowledge of practical electro-mechanical design, testing methodologies, and assembly techniques.
The majority of the Sr. Process Development Technician’s time will be spent in the R&D lab or on the production floor typically tasked with: setting up new test equipment, pilot line setup, troubleshooting issues, building prototypes, testing devices and collecting data, developing processes, building fixtures, performing equipment set-up, and updating documentation. The Sr. Product Development Technician will work closely with R&D project teams and will have an excellent understanding of all processes and equipment associated with the product.
Responsibilities will include:
- Understanding Design for Manufacturing (DFM)
- Familiarity with the MS Office Suite
- Background in R&D and Pilot Manufacturing
- Medical device R&D/Manufacturing Experience specifically neurovascular experience
- Minimum two years technical college education or 5+ years of experience in a regulated field.
- Strong mechanical aptitude and math skills.
- Experience in coils, catheter assembly, or stent manufacturing.
- Performing visually detailed close-up work under magnification.
- Solidworks or other 3D CAD software experience a plus.
- Ability to read and create engineering drawings, as well as, diagrams, charts/graphs, and schematics.
- Capable of understanding/following instructions and standard operating procedures, protocols, etc.
- Ability to design and coordinate standard engineering tests and experiments.
- Ability to collect data and prepare standard reports/documentation to communicate results to a technical team (charts/tables/technical display of information).
- Ability to multi-task in a fast-paced environment.
- Demonstrated ability for creative thinking and problem-solving skills.
- Solid Interpersonal and communication skills for effectivity in a team oriented environment
- Understanding of FDA, QRS(GMP)/MDD and ISO or the ability to learn through exposure a plus.
- Technical and/or verifiable on-the-job training in the use of typical shop equipment including drill presses, pressurized air tools, etc.
- Technical and/or verifiable on-the-job training in part measurement and inspection techniques.
- Hands on, motivated attitude. Takes initiative and able to complete tasks with minimal assistance.
- Execution of prototype development and testing processes as well as the ability to apply appropriate methods with direction from managers and project engineers.
- Perform troubleshooting of products and processes as related to electrical and mechanical components, both custom and off the shelf.
- Work with engineering in developing, troubleshooting, and improving methods and procedures.
- Work cooperatively and professionally with all groups and personnel, within the company or external.
- Mechanical assembly of custom prototypes and equipment.
- Support test method validation activities.
- Completing assignments with general supervision to meet established schedule.
- Contributing ideas and proposing solutions to issues for products in testing.
- Demonstrate an ability to learn new technologies and testing processes in a timely manner.
- Demonstrate strong attention to detail to prevent and minimize defects.
- Conduct testing and analyze data utilizing basic statistical methods.
- Able to discriminate, analyze and offer conclusions to difficult laboratory testing problems.
- Communicate and train technical tasks and abilities to fellow staff.
- Willingness to travel up to 20% domestically and internationally, depending on project needs.