Senior Mechanical Engineer

Working within Bio‑Rad's Clinical Diagnostics Group R&D organization as an Instrument Engineer with Mechanical Engineering background, you’ll take engineering concepts and requirements and transform them into functional prototypes and finished products that improve healthcare outcomes for people around the world. Leveraging your knowledge of engineering principles and best practices, you’ll have an active role in the development and testing of new products.

You'll also collaborate with a multi‑disciplinary team of engineers and scientists, providing your technical knowledge and insights to ensure our products deliver the highest levels of quality and functionality. As a Senior Mechanical Engineer, you will participate and provide leadership in the mechanical design of new electromechanical IVD instrumentation and consumables. This includes providing specifications creation, performing engineering modeling and analyses, developing test methods and fixtures, documenting, and communicating the design to internal stakeholders and external suppliers.

This role demands significant creativity and will require experience using best engineering practices in the design, analysis and verification of components, assemblies, mechanisms, and systems.

• Design, develop, prototype, measure, modify, and test mechanical systems as part of electromechanical equipment development. Specification and qualification of new mechanical designs.
• Design with knowledge of materials and manufacturing processes and understand the interdependencies/design constraints with other project team members.
• Exhibit cooperation and sound judgment in design tradeoffs resulting in reliable designs.
• Design for:
  Quality, Reliability, Serviceability, Manufacturability, Test and Product Cost while meeting the needs of the customer. Complete new equipment/component installations, preventative maintenance activities, and emergency repairs with proper supporting documentation in compliance with Quality Assurance.
• Conduct simulation of systems as appropriate to assure product performance.
• Diagnose the causes of system failures and specify solutions.
• Support production of final product by troubleshooting process and component problems.
• Provide engineering support to Manufacturing, Materials, Test Engineering, and Service to facilitate transfer of designs.
• Assess field reliability data and improve existing product designs as necessary.
• Shepherd projects through the design control process (design specification, design review, risk analysis, etc.), and support New Product Introduction personnel in initial builds (procurement, assembly, troubleshooting).

• Maintain rigorous documentation for all phases of product development, including design specifications, test plans, CAD models, drawings, and change orders associated with IVD instruments and accessories.
• Participate in developing & executing project plans, adhere to milestones, and manage concurrent projects.
• Routine communication with peers and supervisors including documentation of work, meetings, and decisions. Ensure that meetings, project reviews and action lists are kept current and communicated to all stakeholders in a timely fashion.
• Interface with manufacturing and supply chain teams to ensure smooth transfer of products into production.
• Direct outside contract personnel as needed for completion of specific tasks.

• Support compliance to regulatory requirements including electromagnetic interference/electromagnetic compatibility (EMI/EMC), Underwriters Laboratories (UL), REACH/RoHS and other environmental standards.
• Perform work in adherence to the Quality Management System (QMS), including development and maintenance of documentation.
• Ensure designs meet requirements regulated by FDA, UL, IEC, CE, and other governing bodies.
• Participate in selection of vendors and fabrication sources to assure quality and compliance to released specifications.

• Education:
  
  B.S. in Mechanical Engineering is a must.
• Work Experience:
  
  5+ years industry related experience.
• Strong…