Description
A
bout the Company - SomnoMed® is a global medical device company, founded in 2004 and listed on the Australian Stock Exchange, operating in 28 countries. With headquarters in Sydney, Australia, and offices in Europe and the United States, SomnoMed® specializes in developing and manufacturing clinically proven medical devices for the treatment of Obstructive Sleep Apnea (OSA). Our oral appliances have successfully treated patients worldwide with mild and moderate OSA, providing comfortable and effective solutions. SomnoMed® is a leader in developing OSA devices, with each appliance custom-made using state-of-the-art technology to deliver precision, comfort, and first-time fit solutions. We are committed to continuous improvement, ensuring that our oral sleep medicine devices are highly effective and comfortable. Our devices have received FDA 510(k) clearance and are manufactured in accordance with ISO 13485 quality standards.
About the Role - This position’s systematic and rigorous approach, as well as the commitment to excellence and strong leadership by example skills will be the driving force behind maintaining manufacturing standards at the pinnacle of quality and compliance. As a catalyst for change, the said position will lead continuous improvement projects and play a pivotal role in existing projects, including the industrialization of our pioneer connected oral appliance technology.
Responsibilities
Health and Safety Compliance
- Ensure a safe working environment during the shift by adhering to health and safety protocols, conducting safety training, and addressing any safety concerns promptly.
- Ensure workers and equipment meet performance and safety requirements
People Management
- Key implementor of 5S and Lean Principles to optimize workflow and increase efficiency.
- Clearly communicate any changes in processes, targets, or expectations to avoid misunderstandings and ensure alignment.
- Clearly communicate with other teams/s of any improvement activities / implementation plans to avoid misunderstandings and ensure alignment.
- Support workers as questions, concerns, or feedback arises
Quality Assurance
- Establish targets for production, and coordinate a plan to meet those targets
- Assure products meet quality standards
- Develop effective production plans, enhance process efficiency, and ensure optimized output.
- Collaborate with the quality assurance team to implement corrective actions and prevent non-conformities related to production processes.
Production Management
- Overseeing all aspects of the day-to-day operations of the manufacturing process.
- Ensure production stays on schedule
- Proactively identify wastes that directly cause bottlenecks and process inefficiencies and discover opportunities for process improvement to optimize production performance.
- Responsible for optimizing production processes through effective line balancing and capacity planning.
- Monitor production costs, material usage, and equipment efficiency during the shift to identify opportunities for improvement without compromising product quality and delivery.
Continuous improvement
- Knowledgeable in doing process validation/ trial/ evaluation
- Analyze production data and optimize for efficiency
- Can create/ perform process/ equipment qualifications
- Direct an efficient layout of equipment and flow of materials
- Focused on improving efficiencies and processes in a facility
- Watch for hiccups in the process, and look for opportunities to improve operations
- Perform failure analysis and root cause investigations for the defects encountered in Production line and test-related defects.
Reporting and Documentation
- Track productivity and efficiency metrics covering the set targets to identify areas for improvement.
- Collect, analyze, and report on production data to identify trends, ensure target compliance, and support continuous improvement initiatives.
- Can perform data analytics/ analysis
- Utilize statistical methods and data analysis tools to assess product performance and yield.
- Generate detailed test reports and validation summaries, providing recommendations for product or process enhancements.
- Maintain comprehensive documentation to ensure test repeatability and compliance.
Quality Check (QC)
- Incoming Quality Checks, In-Process Checks, and Final Quality Checks - for the raw materials, components, processes, finished devices and finished goods that are in the Pre-Production Stage.
Audit Activities
- May participate or lead Internal Audit Activities in SomnoMed Philippines and its Group of Companies.
Qualifications
- Bachelor's degree in industrial engineering or relevant field is required
- More than 2-3 years of experience in manufacturing as Process Engineer
- Must understand Standard Operations Procedures, Work Instructions
- Good in Oral and Written Communication
- Meticulous, well-organized and able to work in a team environment.
- Able to work in a fast-paced and deadline-oriented environment
- Proficient in Microsoft Office
- Demonstrated capability in Innovation, Transformation, Commitment to Quality and Customer Centric
- Self-motivated with attitude, passion, and energy in abundance
- Ability to deal with ambiguity
Our mission to improve patients' lives worldwide by providing effective solutions for the treatment of obstructive sleep apnea.
Requirements
Please refer to job description.