MFG & PROCESS TECHNICIAN V (San Rafael)

MFG & PROCESS TECHNICIAN V

Diagnoses problems and performs maintenance of complex equipment; ensures specific manufacturing behaviors are in line with practice and operation standards.

Key Responsibilities :

• New Product / Process Development
• Execute process and test method validation along with design, develop, and qualify tooling / equipment
• Using problem solving and DMAIC tools to solve processes and process improvements
• New Product Introductions
• Manage product transfers from new product development to operations or product transfers from site to site.
• Develop bills of materials and assembly methods documentation while providing any training needed to technicians and assemblers.
• Team Leadership (Primary)
• An effective communicator that prepares status reports, modifies schedules, and manages project plans.
• Communicate to stakeholders, customers, and others informed of project status and / or related issues
• Ability to coordinate a team of engineers and technicians and direct technical work
• Coach / mentor technical topics to junior engineers and technicians during product transfers
• Collaborate effectively with other departments, including Quality, R&D, NPD, and Operations.
• Project Management (Supporting)
• Manage your project timelines and resources effectively.
• Work with cross functional teams while being self-driven
• Manage activities with risk to the project timelines, developing contingency plans, while outlining deliverables and milestones
• Quality, Safety and Regulatory Compliance (Supporting)
• Work with Quality Team to ensure all manufacturing processes and equipment comply with FDA regulations, ISO standards, and other relevant industry guidelines
• Comply with safety and security procedures and report potentially unsafe conditions when using equipment and materials properly
• Manage design requirements like Bioburden or Particulates, Biocompatibility and Cleanroom Environment compatibility

Required Skills & Experience :

Typically requires 5-6 years or more of related work experience. Requires high school diploma. Completion of an AA degree or equivalent is preferred.

Values : Integrity, Accountability, Inclusion, Innovation, Teamwork