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Senior Manufacturing Engineer

hace 2 horas

Tijuana, Baja California, México Outset Medical A tiempo completo

Company Overview

Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve "better" now, not some day.  

At Outset we're revolutionizing an industry and changing lives. We're impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We're giving providers time back to focus on patient care. And we're giving patients the power to take control of their life and get back to enjoying the things they love.

Position Overview

The Senior  Manufacturing Engineer 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. Good communication, interpersonal skills and analytical skills are needed in this role.

Essential Job Functions and Responsibilities

  • 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 high-volume low mixed manufacturing environment to ensure product supply is not impacted.
  • Identify and implement continuous improvement projects related to first pass yield, cycle time reduction, product reliability, capacity improvements, and cost reduction.
  • 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 (Work instructions, procedures, BOMs, Routings, PFMEA, Rework instructions, drawings, etc.).
  • Responsible for process and equipment validation (IQ/OQ/PQ/MSA activities).
  • Work with PMO team to adhere with project schedules and finding creative ways to shorten timelines.
  • Initiate corrective and preventive 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.
  • Support Nonconformance (NC) processes by leading investigations, defining rework or repair instructions, and providing data-driven disposition justifications in compliance with quality system requirements.
  • Maintain and update engineering performance metrics, including Scrap, First Pass Yield (FPY), and Rolled Throughput Yield (RTY); analyze trends and drive corrective actions to improve key process indicators.
  • Lead engineering projects from concept through implementation, ensuring timely delivery, budget adherence, and alignment with business priorities.
  • Provide regular status updates to stakeholders, including project milestones, risk assessments, and mitigation plans.
  • Conduct ROI and cost-benefit analyses to justify project investments and measure the effectiveness of implemented improvements.
  • Support additional activities, as assigned.
  • Actively and independently work with cross-functional teams.

Required Qualifications

  • B.S. in Industrial Engineering or similar technical field.
  • 5+ years of experience in the manufacturing/ design of medical products, with a strong background in the manufacturing & development of disposable/single use medical devices.
  • Experience with high volume manufacturing assembly processes.
  • Strong knowledge of FDA quality system regulations, GMP, and ISO 13485 requirements.
  • Strong track record in design, testing, and manufacturing process development.
  • Strong analytical and technical skill set based on engineering analysis fundamentals.
  • Demonstrated ability to find creative ways to meet tight timelines.
  • Experience managing engineering projects.
  • NPI experience.
  • Proficient in Microsoft Office Suites, Minitab, Visio, AutoCAD and SolidWorks.
  • Must be able to communicate fluently in both written and spoken English. 

Desired Qualifications

  • Green Belt certified
  • Ability to multi-task and manage multiple assignments in a timely manner.
  • S. in Industrial Engineering (or similar).
  • Experience with extrusion, ultrasonic welding, tube set manufacturing, and injection molding technologies.
  • Design for manufacturability and cost optimization experience.
  • SolidWorks experience.

Company Culture

At Outset, we believe every person matters. Every Outsetter, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers. 

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU, our future Outsetter. At Outset, we've designed a professional world that our employees are honored and impassioned to belong to, one that offers challenge, the ability to collaborate with great people, and opportunities to build skill and expertise in a fulfilling career. 

An opportunity at Outset Medical won't just be about finding a job. Our culture revolves around the principles of moving farther, faster, together, so working here feels like a masterclass in peak performance, for individuals and teams. 

Privacy is important to us. Please review our Applicant Privacy Notice. 

Important Notice

We have been made aware of fraudulent activities where individuals are impersonating our company and offering fake job opportunities. Please note, Outset Medical will never request payment or gift cards during the hiring process, nor will we ask you to purchase your own equipment. Anyone reaching out to you with an email address ending in , is not a legitimate Outset representative. For legitimate opportunities, always apply directly through our official careers page. If you are unsure about the authenticity of a communication, contact us immediately at

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.