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.

IT Business Analyst

This position will report directly to the VP of Finance with dotted line reporting to VP of manufacturing.

The mission of the Business Analyst is to support the many projects undertaken by the company.
This individual should be able to translate the needs and challenges from different departments, specifically finance and manufacturing, into processes, solutions, and reports using the ERP system, SAGE X3. This role requires on-site support at company’s US headquarters in Irvine.

Primary responsibilities include (but are not limited to);

· SAGE X3, ensuring user support on SAGE X3 in coordination with the global function

· Attend SAGE X3 workshops

· Help users to define functional rules

· Support SAGE X3 users in day to day operations

· Assist with technical setups in SAGE X3

· Security Access/Role definitions and creation

· User Interface updates related to information access and procedural efficiency, business process redesign/efficiency improvements for Sage X3 utilization improvements

· Data extracts and data loads (ETL processes)

· SAP Crystal Report development

· Sage Query Writing

Skills

o Initial training (qualification, curriculum and diploma) MIAGE or equivalent

o Experience level: 5 or more years in similar roles, ability to understand technical documentation.

o Knowledge of and experience with SAGE X3

o Ability to write queries and understand/organize data tables

o Ability to work effectively in a team environment

o Good intra-personal skills

o Written and oral communication

o Ability to interface with all levels of management

o Technical skills; understanding of Accounting, Management control, Financial flows, ERP, Project management, Business Process design

o Behavioral/Interpersonal skills: Active listening, translation of customer requirements, training others, documentation, explaining clearly and effectively

o Strong organizational skills
Education:

Minimum high school degree, accounting certifications/college degree a plus.

Manufacturing Engineer

You will have the responsibility to support and continuously improve current manufacturing processes, through technical and process innovation for the manufacturing of neurovascular medical devices that save patient lives.

Job Responsibilities

  • Daily work includes both sustaining and project work – improving safety, quality, output and eliminating scrap and other forms of waste.
  • 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.

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Qualification Requirements Skills

  • 1. Evaluate manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors; soliciting observations from operators.

2. Develop manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.

3. Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout using principles such as Lean Manufacturing and Six Sigma methodologies.

4. Assure product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes.

5. Provide manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.

6. Organize and trend manufacturing data to help model cost and capacity to help plan and prioritize improvement projects.

7. Training and guiding technicians and operators to execute protocols and procedures.

8. Design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality.

9. Understand manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.

10. Strong analytical, problem solving and project management skills.

11. Demonstrated leadership capability in team settings.

12. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

13. Strong organizational skills, as well as attention to detail.

Pre-requisites/Job Experience

1. Four-year technical degree required, preferably in Engineering.

2. Class III, IIb Implantable Medical Device Experience is a plus

3. Typical experience required is 0-2 years as an Engineer in a related field.

4. Coursework in statistical analysis techniques

5. Neurovascular experience is a plus

6. Strong background in metals, plastics, extrusion, and/or adhesives is highly desired.

7. 3D Modeling or CAD experience required (e.g. Solidworks)

8. Microsoft Project, Microsoft Visio, and Microsoft Access proficiency are highly desired.

9. A demonstrated ability to plan and run projects is highly desired.

Manufacturing Engineering Manager

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

1. Lead a team of Manufacturing Engineers and Technicians in supporting the
ongoing manufacturing of commercial products as well as ensuring flawless
integration of new products into the manufacturing environment.

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

3. 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, improve systems to 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.

4. 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 cGM and a
good understanding in statistics.

5. Creation and maintenance of models for product cost and capacity to help
prioritize engineering and production resources related to improvement projects.

Skills/Qualification requirements

1. Ability to train and manage engineers and technicians in various procedures and skillsets needed to maintain and improve commercial manufacturing

2. Directing engineers who lead project teams tasked with manufacturing improvement projects, manufacturing transfers as well as successful transfers into manufacturing.

3. Ability to prepare project plans, specifications, and schedules for engineering
projects.

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

5. Project Management using MS Project.

6. Knowledge of DFM analysis and techniques to partner with development teams to bring products from pilot manufacturing into commercial manufacturing.

7. Experience with process FMEA as well as Process Development, Process
Characterization and Process Validation.

8. Application of statistical and analytical methods such as SPC, SQC, and DOE.

9. Process background (development, capability, optimization, validation) within the medical device industry including Lean and Six Sigma toolsets to analyze and improve production lines and processes.

10. Development of manufacturing documentation (Manufacturing Procedures,
Engineering Drawings, BOM, Work Orders).

11. Effectiveness with lab equipment, assembly tools and measurement devices.

12. Ability to perform routine analysis of test results in relation to design specifications and test objectives.

13. Characterize and define equipment functional requirements and system capabilities.

14. Development and qualification of tooling/ equipment (IQ/ OQ/ PQ, support, design).

15. Proficiency in SolidWorks.

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

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

18. Experience designing manufacturing line layouts using Lean methodologies

Pre-requisites/Job Experience

1. Four-year technical degree required, preferably in Engineering.
2. Class III, IIb Implantable Medical Device Experience
3. 5 years minimum as an Engineer or engineering leader in a related field.
4. Deep process validation knowledge and medical device or pharmaceutical
experience is required.
5. Equipment Qualification experience
6. Statistical analysis of variable and
7. Neurovascular experience is a plus
8. Strong background in metals, plastics, extrusion, and/or adhesives is highly desired.
9. SolidWorks, Nicelabel, and Statgraphics proficiency are highly desired.
10. Microsoft Project, Microsoft Visio, and Microsoft Access proficiency are highly desired.

Physical Requirements

1. Extended periods of sitting.
2. Extended usage of a microscope.
3. Moderate lifting.
4. Capability to travel Internationally.

Pr. Process Development 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 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.

Qualification Requirements Skills
1. Familiarity with conventional project management methods

2. Strong familiarity with V&V testing for new product designs

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

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

5. Familiar with 510K Testing for FDA approval

6. Project Management using MS Project

7. Knowledge to develop and improve manufacturing processes to pilot production level

8. Experience with design and process FMEA as well as Process Validation

9. Application of statistical and analytical methods such as SPC, SQC, and DOE

10. Process background (development, capability, optimization, validation) within the medical device industry

11. Development of manufacturing documentation (Manufacturing Procedures, Engineering Drawings, BOM, Work Orders)

12. Functional knowledge of probability & statistics, DoE

13. Effectiveness with lab equipment, assembly tools and measurement devices

14. Skills to perform routine analysis of test results in relation to design specifications and test objectives

15. Initiate, design and execute experiments to characterize process variation and control

16. Characterize and define equipment functional requirements and system capabilities

17. Development and qualification of tooling/ equipment (IQ/ OQ/ PQ, support, design)

18. Leading project teams tasked with new process. Product development and the successful transfers into manufacturing

19. Proficiency in SolidWorks

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

21. Equipment and tooling design

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

23. 20% European International travel required

Pre-requisites/Job Experience

1. Four-year degree required, preferably in Engineering.

2. Class III, IIb Implantable Medical Device Experience

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

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

5. Line Layouts

6. Equipment Qualification

7. Statistical analysis skill set is required

8. Neurovascular experience is a plus

9. Strong background in metals, plastics, extrusion, and/or adhesives is highly desired.

10. SolidWorks, Nicelabel, and Statgraphics proficiency are highly desired.

11. Microsoft Project, Microsoft Visio, and Microsoft Access proficiency are highly desired.

12. A demonstrated ability to plan and run projects is highly desired.

Physical Requirements
1. Extended periods of sitting.

2. Extended usage of a microscope.

3. Moderate lifting.