US, US, CA - Aliso Viejo
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: CA - Aliso Viejo
This position will play a key role in product transfer from advanced R&D to production. The purpose of the position is to integrate manufacturability into the development process as well as design and develop any tooling or processes needed to reliably manufacture new designs.
Essential Duties and Responsibilities:
· Participates closely with R&D project teams in design and development of new projects, in anticipation of new product introductions.
· Design jigs/fixtures that ensure materials are produced efficiently and conform to print specification.
· Support the design, manufacture, and coordinate the procurement of dimensional and functional jigs / fixtures for tooling validation
· Support the task of integrating new manufacturing fixtures and equipment in production with emphasis on mistake-proofing
· Coordinate engineering change activities for manufacturing.
· Lead the manufacturing transfer of Class III active implantable spine and orthopedic devices.
· Implements, organizes, and scales up manufacturing processes from pilot line to product launch.
· Review mechanical assembly drawings for complete notes, and attention to DFM
· Develop manufacturing plans, project timelines, requirements, and process flow.
· Conduct manufacturing related design reviews and train in-house personnel.
· Manage installation of new equipment including qualification activities (IQ / OQ / PQ).
· Brainstorm solutions to resolve technical issues encountered during manufacturing.
· Drive process improvements affecting yields, capacity increases, cycle time and cost reduction initiatives.
· Participate in manufacturing risk management activities such as design and process FMEAs
· Interface frequently with internal departments including R&D, Regulatory, Quality, Marketing
· Oversee initial product builds (engineering units, pilot units, process validation units and coordinate a smooth transfer of new products to production.
· Work in accordance with Quality system procedures and actively enforces its objectives
· Process improvement skills including the use of ‘Lean’ tools to drive increased manufacturing productivity, efficiency and safety.
· FDA design controls and clinical good manufacturing processes (cGMP)
· ISO 13485 / CE Mark
· B.S. in Mechanical or Biomedical engineering.
· Minimum of 8 years in medical device manufacturing
· Experience in new product introduction of medical implants
· Excellent analytical, problem solving, technical writing
· Effective cross functional communicator with both internal and external customers and partners
· Up to date with best practices for electronics DFM
· Comfort zone includes creation of advanced custom tooling tailored to new products
· Functional familiarity with the FDA submission process
· Familiar with methods of provided automated/semi-automated processes to improve consistency of process.