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Company Description
Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts.

Job Description
The Process Engineer is a hands-on position providing engineering support to the manufacturing production area including supporting the continuous improvement culture across the operation by actively applying continuous improvement methods to support operations. Drive process improvement activities to achieve tangible improvement in the key business metrics of safety, quality, delivery, efficiency and cost.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

• Analyze and evaluate existing processes and systems within an organization to identify inefficiencies, bottlenecks, and areas for improvement.
• Promote a culture of continuous improvement by implementing lean manufacturing principles and methodologies. Facilitate lean initiatives, such as Kaizen events, 6S and value stream mapping, to drive efficiency, reduce waste, and optimize processes.
• Use various tools and techniques such as time and motion studies, data analysis, and simulation to streamline workflows, eliminate waste, and enhance productivity.
• Design and optimize facility layouts for factory, warehouses, and other operational spaces, while considering factors such as space utilization, material flow, ergonomics, and safety regulations to create efficient and well-organized environments.
• Monitor the overall operations to find new ways to increase efficiency through new production designs.
• Independently identifies process gaps; recommends and implements process improvement.
• Develop a thorough, effective, and timely continuous improvement plan to drive value for internal and external customers.
• Effectively leverage data analytics, engineering methodologies, and core lean tools to enable root cause identification and elimination.
• Evaluate employees’ tasks and responsibilities, identifying procedures or tools to improve productivity.
• Manage the effective operation of the cleanroom by implementing ergonomic improvements.
• Design work schedules, allocate resources efficiently, and implement strategies to improve productivity and maximize the utilization of human resources.
• Identify and implement changes within the operation through data driven, Engineering, and Automation efforts to deliver higher levels of performance in safety, quality, and efficiency.
• Conduct statistical analysis, perform root cause analysis for quality issues, and implement corrective actions to enhance overall quality performance.
• Develop and Implement procedures for manufacturing processes.
• Lead and provide support to quality team for CAPAs, NCRs, Deviations and SCARs
• Investigate and procure state-of-the-art manufacturing equipment for manufacturing process improvement.
• Implement validation protocols for existing equipment, Process and test method validations
• Provide manufacturing summary reports for Management Review Meetings
• Mentor junior engineers in the medical device manufacturing processes and techniques.

Qualifications
• Minimum of a B.S degree, preferably Industrial, Biomedical or Mechanical Engineering, or 4 years of related work experience.
• Minimum of 3-5 years of experience in manufacturing/development environments, with at least 3 years in medical device industry
• Have knowledge of Warehouse Management operations, data analytics, Industrial Engineering, warehouse types (ambient, temp control), warehouse layout/ design and Lean methods Knowledge of material handling solutions and automation types
• Working knowledge of QSR, cGMP, ISO 14971 and ISO 13485
• Understand basic applied statistics, statistical sampling plans, and statistical process control.
• Have knowledge of advance statistical methodologies such as DOE
• Experience in the development and interpretation of SOPs, Work Instructions (WIs) and engineering drawings.
• Strong computer skills in the MS office products.
• Excellent technical writing and interpersonal skills.
• Ability to work effectively in a team environment.
• Have knowledge of Design and change controls.
• Flexibility to operate and self-driven to excel in a fast-paced environment.

Additional Information
Compensation range for this position is:
$82,436- $123,654.

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator – addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

All your information will be kept confidential according to EEO guidelines.

For more information about our company and the work experience, please visitwww.santenusa.comandhttps://www.santenusa.com/career-culture.

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