September 2, 2017
Freudenberg is currently looking for someone to fulfill an engineering manager and would love someone with lean or six sigma experience. I wanted to send this to you in case you’re able to share it with any potential candidates.
Previous experience developing technical staff in a regulated industry
- Direct, manage, and professionally develop Carpinteria Engineers and Technicians.
- Direct responsibility for site technical design transfer activities including: process development, equipment design and selection, risk management, device master record creation, and validation.
- Fosters creative problem solving and innovation solutions with engineering staff.
- Drives development and implementation of new technologies that supports existing business and strategic initiatives.
- Develops and implements standard engineering practices and procedures for Carpinteria and other Freudenberg sites.
- Communicates both internally and externally on projects and production related engineering items as needed.
- Assign and prioritize engineering resources to ensure projects are running per specifications in terms of product cost and product quality while meeting deadlines.
- Manage DMR change requests and quality notifications assigned to engineering to ensure on time product delivery and compliance to quality system.
- Review and approved protocols, reports, engineering orders, purchase requisitions and quality notifications per the quality system, project requirements and industry standards.
- Supports the efforts to generate product quotations, develop test methods, and develop procedures as needed.
- Performs necessary functions to adhere to ISO13485, MDD, and FDA standards.
- Responsible for documented completion of training for staff/employees per current company procedures.
- BS in Mechanical Engineering or other applicable engineering field is required with added disciplines in business management a plus.
- 7 or more years experience in engineering in a manufacturing environment
- 2 or more years experience in managing engineering resources including: tooling, process, project, and design resources.
- 4 or more years experience in a regulated industry; medical device preferred.
- Working knowledge of liquid silicone injection molding, HCR silicone molding, and extrusion processes preferred.
- Previous experience in product design, program management and launching products successfully.
- Familiarity with ISO13485, MDD, and FDA standards.
- Computer literate with knowledge of spreadsheet and word processing packages, and SolidWorks.
- Green Belt certification in Lean or Six Sigma desired.
- Drives team with performance metrics in accordance to business strategies and goals.
- Strong interpersonal, oral and written communication skills with the ability to effectively communicate at all levels of the organization, customers and suppliers.
- Initiative and strong Leadership skills
- Ability to adapt quickly to changing conditions and resolve conflicts
- Ability to plan organize and direct
- Ability to travel as required (minimal)
- Involves sitting, standing and/or walking, with frequent ability to exert up to 15 pounds of force to move objects and occasionally exert up to 30 pounds of force to move objects.
Freudenberg Medical is a global leader in medical contract manufacturing; we offer the following services for medical device, pharmaceutical and IVD clients worldwide − product design and development, silicone and thermoplastic molding and extrusion, complex catheter systems, assembly, packaging, and engineering services.
For nearly 30 years, medical device and healthcare companies around the world have looked to Freudenberg Medical to make a difference as the custom manufacturer medical industry leaders can trust. We operate FDA-registered, ISO 13485 certified medical device facilities with Class 7 & 8 cleanrooms.
Location: Carpinteria, CA
We are currently hiring for an Engineering Manager who is:
- Develops, manages and balances engineering resources for new programs and sustaining improvements for medical devices and contract manufacturing beginning with the development and prototype stages through final production launch
- Driven and focused with a positive attitude on design transfer, validation, and the flawless launch of new products into production for medical devices.
- Self-motivated and thrives in a fast –paced, team-driven, “lean” systems environment, where every day brings new projects and challenges.
It’s an exciting time to work at Freudenberg Medical. We know our ability to succeed depends upon the people we employ. Leading-edge technology, the highest standards, and outstanding people make Freudenberg Medical the employer of choice in this industry. We offer a competitive salary plus a full range of benefits including medical, dental and vision insurance, as well as 401K Match. Learn more at www.freudenbergmedical.com
Growtth and Assembly Cell Manager