Senior Manufacturing Engineer at Outset Medical

Tijuana, Baja California, Mexico

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Dialysis, HealthcareIndustries

Requirements

Strong analytical skills, including use of statistical techniques, lean manufacturing tools, Six Sigma, DOE for process and equipment
Good communication and interpersonal skills
Experience in a high-volume low mix manufacturing environment
Ability to interact with internal resources, external suppliers, and Contract Manufacturers (CM’s)
Technical leadership and Design for Manufacturability (DFM) expertise
Knowledge of engineering and manufacturing documentation (Work instructions, procedures, BOMs, Routings, PFMEA, Rework instructions, drawings)
Experience with process and equipment validation (IQ/OQ/PQ/MSA)
Familiarity with CAPA procedures and Nonconformance (NC) processes
Ability to maintain and analyze engineering performance metrics (Scrap, FPY, RTY)

Responsibilities

Drive process and product improvement activities to promote product quality, manufacturing cost, efficiency, and manufacturability
Resolve technical issues and provide production support to address production issues without impacting supply
Identify and implement continuous improvement projects (first pass yield, cycle time reduction, product reliability, capacity improvements, cost reduction)
Provide 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 meet cost targets
Develop engineering and manufacturing documentation (Work instructions, procedures, BOMs, Routings, PFMEA, Rework instructions, drawings)
Perform process and equipment validation (IQ/OQ/PQ/MSA)
Collaborate with PMO team to adhere to project schedules and shorten timelines
Initiate corrective and preventive actions per company CAPA procedure
Engage with external suppliers to meet project objectives and product performance requirements
Support Nonconformance (NC) processes by leading investigations, defining rework/repair instructions, and providing data-driven dispositions
Maintain and update engineering performance metrics; analyze trends and drive corrective actions
Lead engineering projects from concept through implementation, ensuring timely delivery, budget adherence, and business alignment
Provide regular status updates to stakeholders, including milestones, risk assessments, and mitigation plans
Conduct ROI and cost-benefit analyses to justify investments and measure improvements
Support additional activities as assigned

Skills

Manufacturing Engineering

Lean Manufacturing

Six Sigma

Statistical Techniques

DOE

Tool & Fixture Design

Process Improvement

Product Quality

Contract Manufacturing

Outset Medical

Dialysis treatment solutions and training programs

About Outset Medical

Outset Medical focuses on improving dialysis treatment in the healthcare sector. Their main product, Tablo, is a system that simplifies the dialysis process by integrating with electronic medical record (EMR) platforms, allowing for better management of patient data with real-time updates and alerts. This helps streamline workflows from charting to billing. In addition to Tablo, Outset Medical provides educational programs and hands-on training for dialysis professionals, including a Vascular Access Program that enhances staff skills in cannulation and vascular access management. They also offer a Bridge Program to assist facilities transitioning to in-house dialysis services by providing experienced dialysis nurses for training and support. Outset Medical aims to enhance the quality of care for dialysis patients across various settings, including hospitals, outpatient clinics, and home care.

San Jose, CaliforniaHeadquarters

2010Year Founded

$542.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Medical, dental, & vision

Life Insurance/AD&D

FSA & HSA

401k

Parental leave

Pet insurance

Tuition reimbursement

PTO

Company events

Risks

Multiple class action lawsuits could lead to financial and reputational damage for Outset.

The shipment pause of TabloCart with Prefiltration may have disrupted supply chains.

Reliance on partnerships, like with U.S. Renal Care, poses risks if expectations aren't met.

Differentiation

Outset Medical's Tablo system integrates with EMR platforms for streamlined dialysis workflows.

The company offers a Vascular Access Program to enhance staff expertise in cannulation.

Outset Medical provides a Bridge Program for facilities transitioning to in-house dialysis services.

Upsides

Increased adoption of home dialysis solutions aligns with Outset's partnership with U.S. Renal Care.

The demand for portable dialysis machines supports the market potential for Outset's Tablo system.

Outset's FIPS 140-3 validation enhances cybersecurity, aligning with new medical device standards.

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