Allergan Manager, Medical Device Engineering in Irvine, California
Manager, Medical Device Engineering
Irvine, California, United States at http://agn.referrals.selectminds.com/jobs/196/other-jobs-matching/location-only
Aug 08, 2016Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
At Allergan you will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Summary: Leads, manages and coordinates projects involving new product development, commercial introduction and marketed product support. Roles include product and process design, manufacturing process transfers, production scale-up, validation, launch support and on market technical support.
Essential Job Functions : This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
Member of cross-functional development teams providing operation’s input to product and process design.
Key contributor to design control process throughout product development, influencing product design and design for manufacturability.
Coordinate and direct the activities and functions for new product technology transfer to commercial manufacturing sites providing product and process design input to the Development team, defining and specification of equipment needs, selecting equipment suppliers,
Oversee new product process validation at commercial manufacturing sites.
Coordinate and facilitate transfer of product manufacture to additional site(s).
Technical interface with contract manufacturers, vendors and suppliers.
Provide technical support to currently market products.
Assure that manufacturing transfers and new product introductions meet Regulatory requirements such as: FDA cGMP and ISO 13485.
Support due diligence assessments of potential business development opportunities.
Handles a diverse workload of assignments, covering several disciplines of engineering; maintains proper priority of multiple assignments.
Complies with all Company policies and procedures, including safety rules and regulations.
Establishes and maintains cooperative working relationships with those contacted during course of work; maintains business integrity in all dealings, whether inside or outside of the Company.
Required Knowledge and Skills :
Knowledge of :
Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory and safety compliance requirements and guidelines.
Design Control Process (ISO 13485 and FDA QSR 820).
Device manufacturing process design/DFM and scale-up including equipment, testing, assembly operations and support systems.
Assembly processes and equipment/fixturing (semi-automation, full automation)
Injection molding and plastics extrusion
Process Validation (process and equipment)
- Strong project management and team leadership skills
Implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
Analyzing, troubleshooting and identifying problems, and recommending and implementing methods, procedures and/or techniques for resolution. Problem solving techniques.
Six Sigma/DMAIC process
Communicating clearly and concisely, both orally and in writing.
Establishing and maintaining cooperative working relationships with those contacted in the course of work.
Performing all necessary engineering project functions efficiently and in a timely manner.
Bachelor's degree in Engineering from an accredited college or university in addition to a minimum of fifteen (15) years of engineering work experience, preferably in a medical device development and manufacturing environment, and hands-on or technical training in the field of process engineering.