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.
The successful candidate shall have in-depth knowledge and experience in part design and development of Electrical components and PCBAs for medical device product manufacturing; acts as resource and role model for colleagues with less experience and for vendors. Use standard methodologies and knowledge of internal or external business issues to improve products. Technical lead in his/her respective Electrical and Electronics component design, complex problem solving, and technology evaluation and deployment to enable efficient manufacturing for balanced, large-scale production. Utilize their knowledge of Electrical design, GD&T practices, materials and injection molding processes to optimal engineer custom solutions, develop DFM feedback, improve current designs and collaborate with vendors. He/she shall use the experience in PCBA manufacturing to transition designs from the Concept phase through Development and into Production at the vendor sites. Through these phase gates of product development and/or new product introduction, apply DFMEA, DFM, and CAE tools to develop robust component designs that encourage manufacturing efficiencies for electrical and electronics components through finished device assembly. This is a hands-on position involving detailed design (3D modeling and 2D print specification), testing, prototyping and engineering support of Production; Individual should interface well with team members, scientists, vendors, and operations personnel.
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
- Create, review, and approve Engineering Change Orders for electronic component management
- Design, test, and validate new Electrical component designs in collaboration with multi-disciplined engineering teams.
- Review and approve component specifications from suppliers.
- Participates in electrical schematics reviews, validate components for NPI.
- Lead component specifications in Quality Management System (QMS) and ensure those specifications are applicable to product function and Quality Policy.
- Proactively identify risks in the design of parts, molds, fixtures and methods associated with Electrical components manufacturing and design quality into the component design rather than relying on inspection to detect non-compliance with design or process intent.
- Establish working relationships with vendors for outsourcing of engineering services, materials supply, fixture design, and contract manufacturing of Electrical components.
- Develop high standards for all Electrical component products such that the design intent, quality expectation for patient safety, and finished medical device function are never compromised.
- Lead a core team in failure investigations and root cause analyses as they relate to Electrical parts performance and manage corrective action with suppliers.
- Coordinate Engineering testing, first article inspections, and qualification activities.
- Mentor others to utilize advanced inspection technologies, statistical methods, process data, DOE, to identify required improvements to injection molding tools, processes, and measurement techniques such that robust performance at high manufacturing efficiencies is enabled.
- Write verification and validation protocols and related technical reports to support the transfer of designs into Production and document status of Electrical components throughout a product lifecycle.
- Actively participate in group meetings and be a technical point person in project teams.
- Create custom fixtures and procedures for testing, inspection, or functional evaluation of Electrical parts designs and compliance with specifications or intended use.
- Work with Electrical Design Engineers to select components based on performance, reliability, availability, cost, environmental and manufacturing requirements
- Review electrical BOM's and schematics to drive cost reduction, improve reliability and optimize supply options
- Evaluate all process change notices (PCN's) from electronics parts suppliers and initiate appropriate internal actions
- Proactively manage component EOL and successful transition to qualified replacement candidates
- BS degree in Electrical Engineering with 8+ years' experience as an Electrical Component Engineer with Supplier management experience OR
- Master’s degree with 5+ years of experience OR
- Doctoral degree with 3+ years’ experience.
- The subject matter expert on electrical components
- Strong negotiating and relationship building skills
- Capable of driving in depth discussions on various technologies and trends in the industry
- Experience & understanding of Rack and Cabinet Assemblies, Cables, Cable design and Cable products, Connectivity, Board components, Sensors & Electromechanical components required.
- Familiarity with GMP, ISO, and FDA rules and regulatory requirements for medical device industry.
- Extensive knowledge in GD&T and metrology & Experience in statistical analysis
- 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, Consumer Electronics, or Medical Device industry preferred.
- Ability to travel up to 50% to vendor locations.
- 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
- An active LinkedIn Profile