Senior Mechanical Engineer

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.

Company Overview

Outset is a pioneering medical technology company that puts the patient before the machine. Our human-centered model is designed to dramatically improve not only the care experience – for patients, families, providers and physicians alike – but also cost-efficiency of dialysis delivery. We believe in introducing technology innovation in order to drive service model innovation. And in doing so, we intend to profoundly and permanently impact what, where and who can dialyze.

 

Position Overview  

The Sr. Mechanical Engineer is responsible for executing mechanical design projects on medical capital equipment, including design development, verification, regression, validation, transfer to manufacturing, and sustaining engineering.  The focus of this position is root cause analysis, design conceptualization, testing, documentation, vendor management, and Design Control.  Has a working knowledge of SolidWorks, must be well organized and able to effectively work on multiple projects within a team environment in support of electro-mechanical and fluidic designs with associated documentation. Collaborates and interacts with contract manufacturers, vendors and other Outset departments .  Helps provide guidance and mentoring to junior engineering staff and technicians.

 

Essential Job Functions

• Optimizes existing designs or creates new designs for improved usability, reliability, manufacturability / serviceability, and cost reduction in a cross-functional team environment. Experienced designing machined, formed/stamped, welded, cast and injection-molded parts with cost and ease of manufacturability in mind.
• Responsible engineer for the structural and cosmetic components of the Tablo Console. Serves as a subject matter expert in sheet metal, machining, casting, welding and other manufacturing processes and the DFM of related components and assemblies.
• Executes multiple design projects simultaneously, including: root cause of issues, conception and development of solutions, prototyping, verification testing, and design transfer to manufacturing.
• Uses SolidWorks in the creation of complex models, assemblies, fabrication and assembly drawings, and Finite Element analysis. Uses experience with sheet metal, cable routing, master modeling and surfacing techniques to create and revise designs.
• Knowledgeable with Geometric Dimensioning and Tolerancing standards and their application.
• Participates in root cause analysis and troubleshooting activities at the sub-system and component level.
• Works with in-house manufacturing, contract manufacturing, vendors and field service engineers to identify issues and opportunities, collaborate on design solutions and drive change.
• Analyzes various design requirements and recommends possible solutions or alternate constructions.
• Makes various calculations such as strength of materials, mass properties, statics, dynamics, kinematics, stresses, mechanical tolerance stack-ups and statistics.
• Uses cost/benefit, FMEA, clinical hazards analysis and other engineering analysis to determine best path to design optimization. Makes data driven recommendations and decisions.
• Prepares technical presentations and presents designs to Engineering, cross-functional team members and Risk Management team.
• Writes test protocols and reports to provide supporting evidence for proposed changes. Performs testing and/or supervises test technicians in the execution of protocols.
• Ensures all necessary documentation is complete such as engineering prints, bills of materials, specifications and manufacturing instructions to allow successful transfer to manufacturing.
• Creates Change Orders within the Quality Management System utilizing Agile document control system. Writes clear and concise descriptions of and reasons for change, and justifications for change acceptability.
• Works closely with other departments such as Quality, and Supply Chain to evaluate, select and develop suppliers to join the Outset global supply chain.

 

Requirements/Qualifications:

• A Bachelor’s degree in a relevant Engineering field. A Bachelor’s degree in Mechanical Engineering is preferred.
• Must have a minimum of five (5) years of experience in mechanical design and/or manufacturing of capital equipment.
• Medical device company experience is preferred. Experience with low-mid volume capital equipment is ideal.
• Self-starter and independent, capable of working as a member of a US/MX engineering team.
• Experienced with SolidWorks, Solidworks Enterprise PDM and Agile document control system preferred.
• Solidworks Simulation (Static Structural FEA) experience preferred.
• Excellent Project Management skills.
• Excellent English and Spanish communication skills, both verbal and written.

Ability to travel between the US and MX, and to overseas suppliers as required.

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 @outsetmedical.cc, 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 peopleops@outsetmedical.com.

 

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.