Senior Diagnostic Consumables Engineer
At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).
As a Senior Diagnostic Consumables Engineer, you will be a part of a fast-pace, multi-disciplinary, and creative team that drives new product development and implements continuous improvements to new and existing processes. The successful candidate must be able to use their knowledge of mechanical design, materials, automation, and injection molding to transition designs from the Concept phase through Design and Development and into Production. The ability to help develop products, trouble-shoot, define root cause, provide resolution, and implement the necessary changes efficiently in an FDA regulated environment is critical. The ability to identify problems and create solutions through research and solid technical principles/disciplines is necessary. This is a hands-on position involving detailed design, laboratory testing, prototype fabrication, engineering studies, and Engineering support of Production; must be able to interface well with cross-functional interdisciplinary teams of engineers, scientists, vendors, and operations personnel. There are no direct reports to this position.
- This position entails a high level of organization, excellent communication skills, and rigorous process discipline and documentation to assure functionality, safety, reliability and quality of the product.
- In support of New Product Development (NPD) efforts, use knowledge of mechanical design for prototyping and hands-on lab testing in engineering and biology labs to develop and enhance part attributes; work with design engineers to optimize design drawings and supplier manufacturing processes so that high quality parts are consistently delivered.
- Apply hands on experience with design for manufacturing (DFM), material selection, prototyping, process development, , and validations.
- Test and validate new consumable designs in collaboration with diverse functional groups from initial design to market and manufacturing release.
- Determine and execute the most appropriate testing to address process and system level performance issues involving cartridge consumables.
- Create custom fixtures and procedures for testing, inspection, or functional evaluation of consumables parts designs and compliance with specifications or intended use.
- Write verification and validation protocols and related technical reports to support the transfer of designs into Production and document status of consumables throughout a product lifecycle.
- Develop and document business practices, processes, procedures, and work instructions.
- Analyze complex data via statistical methods and provides written and oral reports and updates to senior and executive management.
- Assist in Problem Solving, Failure Analysis, and Corrective and Preventative Actions as they relate to consumables part performance in high speed automation environments.
- Promote a culture of structured problem solving and enforce high standards for all consumables products such that the design intent, quality expectation for patient safety, and finished medical device function are never compromised.
- Establish working relationships with vendors for outsourcing of engineering services, equipment design, and analytical testing of consumables components.
- Actively participate in group meetings and be a technical point person in project teams.
A qualified candidate must:
- Have a Bachelor's degree in Engineering plus 6-9 years of related work experience with a good understanding of specified functional area or equivalent combination of education and experience to perform at this level.
- Have strong analytical and troubleshooting skills to understand system interfaces and be able to quickly analyze, troubleshoot, and resolve system interoperability problems.
- Have working knowledge of design of experiments, interpretation of test results, failure investigation and excellent problem solving skills
- Have excellent communication skills. Must be able to communicate verbally in an efficient and effective manner and be proficient in document preparation and editing, including detailed test planning and report writing.
- Be proficient with standard Microsoft Office applications.
- Be able to analyze and reduce data to a coherent form for clear presentation.
- Have experience with creating drawings, BOMs, product specifications, and engineering drawings.
- Have demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes and policies.
- Have demonstrated biology laboratory skills, including pipetting
- Have demonstrated engineering laboratory skills
- Have demonstrated ability to prioritize and manage multiple, concurrent projects in a fast-paced environment
- Experience with high volume manufacturing processes, including machining, extrusion, injection molding, ultrasonic welding.
- Proficiency with data analysis software such as Matlab, R, Minitab, or Excel in order to conduct statistical analyses on collected data.
- Proficiency with SolidWorks
- Basic machining skills are a plus.
- Industry experience in medical device consumables.
- Experience in project management fundamentals.
- Working knowledge of GMP, ISO, and FDA rules and regulations is highly desirable.
- Assay development experience and/or microfluidics expertise is highly desirable.
- Working knowledge of design of experiments (DOE), Failure Mode Effects Analysis (FMEA), and Statistical Process Control (SPC) is highly desirable.
- Experience with failure investigations and root cause failure analysis is a plus.
- Experience in process development and DMAIC is a plus.
- Experience working with biological samples in a medical device development environment is a plus.
- Experience with Polymerase Chain Reaction (PCR) or other biological applications of fluorescence-based techniques is a plus.
Ability to lift 10 to 20 lbs.
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.