Manufacturing Engineer
hace 1 semana
Company Overview
Outset is a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis.
The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers.
Tablo serves as a single enterprise solution that can be utilized across the continuum of care, allowing dialysis to be delivered anytime, anywhere and by anyone.
The integration of water purification and on-demand dialysate production enables Tablo to serve as a dialysis clinic on wheels, with 2-way wireless data transmission and a proprietary data analytics platform powering a new holistic approach to dialysis care.
Position Overview
The Manufacturing Engineer - Disposable will act as an individual contributor within the Manufacturing Engineering team to develop and improve upon the disposables/consumable products utilized within the Tablo System.
This person will interact with both internal resources, as well as external suppliers and Contract Manufactures (CM's) to develop and transfer new products into production and improving sustaining products in accordance with established policies, goals and objectives.
Responsibilities/Functions
- Drive process and product improvement activities to promote product quality, overall manufacturing cost, efficiency and manufacturability using statistical techniques, lean manufacturing tools, Six Sigma, tool & fixture design, and DOE for process and equipment.
- Resolve technical issues and provide production support to quickly address production issues in a highvolume low mixed manufacturing environment to ensure product supply is not impacted.
- Provides technical leadership and Design for Manufacturability input to product development teams.
- Work closely with R&D through development and production release of new products to manufacturing and meeting cost targets.
- Responsible for developing engineering and manufacturing documentation.
- Responsible for process and equipment validation.
- Work with PMO team to adhere with project schedules and finding creative ways to shorten timelines.
- Initiate corrective action in accordance with company CAPA procedure.
- Engage with external suppliers to ensure project objectives are met and that product performance meets customer and quality requirements.
- Actively and independently work with crossfunctional teams.
Required Qualifications
- B.S. in Mechanical Engineering or similar technical field.
- Minimum of 7 years of experience in the manufacturing/ design of medical products, with a strong background in the manufacturing & development of disposable/single use medical devices.
- Strong knowledge of FDA quality system regulations, GMP, and ISO 13485requirements.
- Strong track record in design, testing, and manufacturing process development.
- Demonstrated ability to find creative ways to meet tight timelines.
- Strong communication skills in matrixed environment.
- NPI experience.
- Strong analytical and technical skill set based on engineering analysis fundamentals.
- Proficient in English and Spanish
- Green Belt certified preferred.
- Experience with high volume manufacturing assembly processes.
- Strong computer skills, Microsoft Office Suites, Visio, Minitab, Visio.
Desired Qualifications
- M.S. in Mechanical Engineering (or similar).
- Experience with extrusion, ultrasonic welding, tube set manufacturing, and injection molding technologies.
- Design for manufacturability and cost optimization experience.
- SolidWorks experience.
Applicant Privacy Notice.
EQUAL EMPLOYMENT OPPORTUNITY STATEMENT
Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace.
We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws.
This policy applies to all employment practices within our organization.-
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