Primary Location: US-CA-Valencia
Additional Locations: (n/a)
Requisition ID: 102453
Why join Boston Scientific Neuromodulation in California?
We integrate all global operations at our worldwide headquarters in Valencia, California, close to Los Angeles, close to the beach, close to the mountains, close to the desert. All the advantages of Southern California but more affordable than many other areas nearby. Looking for onsite amenities? We have an on-campus bistro, credit union, gym, and Toastmasters club. Take advantage of 360 days of sunshine a year on our basketball and volleyball courts. Join our softball and soccer teams. We even have cricket and dragon boat racing teams! We also offer numerous volunteer activities and events in the wonderful communities of Valencia and Santa Clarita. If you like to work hard and play hard, you'll fit right in. And you'll be well rewarded. Our salaries are competitive. Our benefits package is generous. And our 401K program? Forbes ranks it one of the top 10 in the country!
What makes Boston Scientific Neuromodulation so special?
We've seen the difference that neuromodulation technology such as spinal cord stimulation and deep brain stimulation can make. These breakthroughs have helped more than 400,000 people worldwide over the past four decades. But there is still enormous potential to help even more people. In our drive to be the world leader in neurological devices, we strive to improve every life we touch through our dedication to innovation, our commitment to people, and our passion for performance.
A results-oriented manufacturing engineering manager with experience in the manufacture and production testing of printed circuit board assemblies (PCBA) and electro/mechanical assembly processes. Must be capable of partnering with suppliers to develop and validate new processes & equipment. Needs to possess project management and problem solving skills with the ability to handle multiple issues concurrently. Responsible for initiation and management of projects pertaining to manufacturing of existing products and new product introductions into production. Develops and reviews DFM / DFA analysis focused on assuring electro-mechanical design and manufacturing integrity. Directs cross functional teams to meet project objectives. Communicates project status to all levels of management. Strong verbal, written, and interpersonal skills; and the ability to work within a team required.
- Supervise engineers and technicians supporting existing products and new product development.
- Eliminate/reduce defects and improve yields. Perform root cause analysis and take corrective action to resolve test failures.
- Generate change orders to existing documents. Review documentation generated by others relating to product responsibilities.
- Development of detailed manufacturing documentation and parts lists.
- Identification and execution of Value Improvement Projects (VIP).
- Manage component replacement projects for end of life (EOL) components.
- Participate on multi-disciplinary project teams, representing Mfg Eng. function for team activities and decisions.
- Responsible for "Pulling" new products from R&D.
- Key Operations technical member on project core and extended teams from concept through launch.
- Provide operations input in early supplier development and quality planning.
- Responsible for driving "Design for Manufacturability".
- Responsible for managing and leading process development efforts.
- Responsible for estimating and managing project costs.
- Review and approve process capability and characterization studies.
- Review process FMEA.
- Review and approve process validation plans and reports.
- Responsible for coordinating development activities for all manufacturing equipment, production tools and fixtures to support pre-production builds and product launch.
- Create and maintain manufacturing documentation.
- Coordinate pre-production and pilot production builds.
- Manage transfer of new products and processes to commercial production.
- Support implementation of Lean principles.
- Disposition non-conforming material and product.
- Resolution of supply chain issues affecting material availability and quality.
- Management and support of CAPA projects.
- Development and implementation of appropriate supporting documentation, which complies with QSR and GMP in conjunction with the other team members.
- Detailed project planning of major projects and product/process transfers.
- Demonstrate a primary commitment to product quality.
- Understand and comply with all the regulations governing the quality systems.
- Bachelors Degree is required preferably in Engineering or other related technical field or equivalent experience.
- BSEE or BSME + Min of 10 years directly related experience
- MSEE or MSME + Min of 8 years directly related experience
- A minimum of three years of functional supervisory/management experience is required.
- A minimum of three year project leader/manager experience is required.
- Prior experience creating and managing budgets with a focus on cost effectiveness is required.
- Significant experience in electro-mechanical manufacturing integration and troubleshooting
- Demonstrated history of successfully commercializing electro-mechanical devices with embedded software
- Working knowledge of PCB and PCBA manufacturing processes.
- Experienced & in-depth knowledge in SMT, Mechanical assembly, soldering, cleaning processes, etc. Knowledgeable in various PCB laminates and their processing.
- Familiarity with electronics manufacturing industry standards and practices (e.g. IPC 600/610)
- Experience in working with component suppliers for root cause analysis.
- Experience with test automation, schematics and interpret and understand Gerber files.
- Proficiency operating equipment such as oscilloscopes and spectrum analyzers
- Strong project management skills. Prior experience creating and executing project plans
- Medical industry experience in a manufacturing capacity preferred.
- Working knowledge of Lean and/or 6 Sigma
- Working knowledge of quality systems, ISO 13485 and FDA QSR for medical devices preferred
- Proven experience in equipment and process validation, required.
- Hands-on experience developing and troubleshooting new and existing processes.
- Fluent in statistical data analysis, statistical process control (SPC), design of experiments (DOE), design for manufacturability (DFM), failure mode and effect analysis (FMEA).
- Experience with transfer of new products to production.
- Proven ability to interface with R&D and Production.
- Excellent oral and written communication skills demonstrated by the ability to communicate across all levels within and outside of the organization.
- Positive attitude, team player, self motivated, ability to work with little supervision.
- Project Management coursework required (PMI certification a plus)
- Strong daily use of web-based applications and Microsoft Office products (Word, Excel, Project, Outlook, PowerPoint) is required. SAP, PDM and Minitab experience is a plus.
Boston Scientific is an Equal Opportunity Employer.
Boston Scientific is an Equal Opportunity Employer.
Posting Notes: US-CA-Valencia||(n/a)||Manufacturing & Operations||(n/a)
About Boston Scientific
Boston Scientific Corporation is a developer, manufacturer and marketer of medical devices that are used in a range of interventional medical specialties, including cardiac rhythm management, electrophysiology, interventional cardiology, peripheral interventions, neurovascular, endoscopy, urology, womens health and neuromodulation. The Companys products are offered for sale principally by six dedicated business groups: CRM, including its Cardiac Rhythm Management and Electrophysiology businesses; Cardiovascular, including its Interventional Cardiology and Peripheral Interventions businesses; Neurovascular; Endoscopy; Urology/Womens Health, and Neuromodulation. During the year ended December 31, 2009, it derived 31% of its net sales from its CRM group, 43% from its Cardiovascular group, 12% from its Endoscopy business, 6% from its Urology/Womens Health business, 4% from its Neuromodulation business, and 4% from its Neurovascular business.