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

We are seeking a highly skilled Supplier Development Engineer to join our dynamic team. The Supplier Development Engineer will play a critical role in ensuring the quality and reliability of components and materials supplied to Outset Medica. This position involves close collaboration with suppliers to qualify new suppliers, drive continuous improvement, resolve technical issues, and enhance overall supply chain efficiency.

Outset is a fast moving, dynamic environment where flexibility and adaptability are key attributes needed for success. The successful candidate will be a highly motivated self-starter with Electrical Components expertise in consumer electronics, automotive or healthcare industries. 

 

Essential Job Functions and Responsibilities

  • Lead the qualification process for new suppliers, ensuring they meet Outset's standards for quality, reliability, and regulatory compliance.
  • Collaborate with suppliers to implement continuous improvement initiatives aimed at enhancing product quality, reducing costs, and increasing efficiency.
  • Investigate and resolve supplier-related quality issues through root cause analysis and corrective action implementation, working closely with cross-functional teams.
  • Support regular audits of existing suppliers to assess their manufacturing processes, quality management systems, and adherence to specifications.
  • Establish key performance indicators (KPIs) to monitor supplier performance and ensure compliance with contractual agreements. Proactively identify and address any deviations from agreed-upon standards and specifications.
  • Assess supplier risk factors and develop strategies to mitigate potential risks to Outset's supply chain, ensuring business continuity.
  • Stay abreast of relevant regulations and standards in the medical device industry, ensuring that suppliers comply with applicable requirements.
  • Collaborate with cross-functional teams to identify and evaluate potential suppliers based on sustainability criteria, quality standards, cost competitiveness, and capacity.
  • Lead parts specifications in Quality Management System and ensure specifications are applicable for reliable product functionality.

Required Qualifications

  • Bachelor’s degree in Engineering (Mechanical, Electrical, System, Mechatronic)
  • 8+ years of experience in supplier development, quality engineering or related roles within the medical device industry
  • Strong understanding of quality management systems (ISO 13485, FDA regulations, etc.).
  • Proven track record of driving continuous improvement initiatives and achieving measurable results.
  • Ability to travel domestically and internationally as needed.

Desired Qualifications

  • Strong negotiating and relationship building skills
  • Capable of driving in depth discussions on various technologies and trends in the industry
  • Familiarity with GMP, ISO, and FDA rules and regulatory requirements for medical device industry.
  • Working experience with creating drawings, BOMs, product specifications, and engineering drawings.
  • Proficiency with SolidWorks, MiniTab, and Microsoft Office applications.
  • A strong understanding and ability with PLM software
  • Ability to prioritize and handle multiple, concurrent projects.
  • Excellent verbal and written communication skills, anticipative and forward thinking
  • Team attitude; eager to cooperate with others with exceptional interpersonal communication skills
  • Experience in a start-up environment strongly preferred
  • A background in the automotive, aerospace, or medical device industry preferred.
  • Ability to travel up to 50% to vendor locations (domestically and internationally).
  • Strong analytical skills, ability to leverage qualitative and quantitative data to resolve concerns and enhance decision making.
  • A strong sense of integrity and dedication to ethical business practices

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. 

And this doesn’t happen by accident. It starts with our live onboarding program, Bold Beginnings, which serves as an incubator for cross-functional team-building, an immersion in Outset’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry. In SPARK!, people managers across functions come together to master three pivotal conversations: 1) the priority conversation, 2) the performance conversation, and 3) the growth conversation. They do this in an environment that challenges, supports, and broadens mindsets. 

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. 

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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