At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert System, weve 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).
The Cepheid Consumables Engineering team is seeking a Senior Diagnostic Consumables Engineer who will apply their experience with injection molded plastics to transform product requirements into sustainable, large-scale consumables production. The successful candidate will use their knowledge of mechanical design, materials, automation, and molding to engineer custom solutions, improve current designs, and enable large scale manufacturing of consumables for the medical device industry. This is a hands-on position involving testing, prototype fabrication, and Engineering support of Production. Ability to interface well with other engineers, scientists, vendors, and operations personnel.
Essential Job Responsibilities:
Maintain and/or improve existing consumables parts production, with an emphasis on refining part specifications, improving manufacturability, and achieving cost reductions.
Use 3D CAD modeling, statistical analysis, hands-on bench or line testing to select and characterize material and part attributes, process performance, and assembly characteristics.
Use design for excellence (DfX) experience to develop and validate new solutions to support and enhance consumable product line.
Promote a culture of structured problem solving by proactively identifying risks in the design of processes, equipment, and methods associated with consumables manufacturing and work with multi-functional team to design quality into the equipment or process design rather than relying on inspection to detect non-compliance with design or process intent.
Assist in failure investigations and root cause analyses as they relate to consumables part performance in high speed automation environments.
Coordinate Engineering testing, first article inspections, and qualification activities for validation and verification of consumables components.
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.
Analyze sophisticated data via statistical methods and provides written and oral reports and updates to senior and executive management.
Establish working relationships with vendors for outsourcing of engineering services, equipment design, analytical testing of consumables and/or development of final test requirements to ensure products meet specifications.
Implement high standards for all consumable products such that the design intent, quality expectation for patient safety, and finished medical device function are never compromised.
Actively participate in group meetings and be a technical point person in project teams
Demonstrate ability to prioritize and lead multiple projects.
Demonstrate high level of organization and interpersonal skills, and meticulous process subject area and documentation to assure functionality, safety, reliability and quality of the product.
Education & Experience
Have Bachelors degree in Engineering with 5+ years of related work experience OR
Have Masters degree in Engineering with 3+ years of related work experience OR
Have Doctoral degree in Engineering with 0-2 years of related work experience
Knowledge & Skills:
Work with minimal direction. Follow established procedures; work will be reviewed for soundness of technical judgment, overall adequacy and accuracy.
Ability learn new methods and tools to analyze product performance and investigate failures.
Have strong analytical and troubleshooting skills to understand system interfaces and to quickly analyze, tackle, and resolve system interoperability problems.
Have excellent communication skills and ability to communicate verbally in an efficient and effective manner
Experience in document preparation and editing, including detailed test planning and report writing.
Have experience with creating drawings, BOMs, product specifications.
Analyze and reduce data to a coherent form for clear presentation.
Ability to understand and align with applicable FDA regulations and Company operating procedures, processes and policies.
Have validated engineering laboratory skills.
Have knowledge and experience in design and production change control processes, design of experiments (DOE), interpretation of test results, failure investigation and excellent problem resolution skills.
Be able to lift 10 to 20 lbs.
Experience with manufacturing processes, including machining, extrusion, molding, ultrasonic welding.
Experience with plastic injection molding and part design
Experience with GD&T (Geometric Dimensioning and Tolerancing), quality measurement technique, and use of SolidWorks.
Proficiency with data analysis software such as Matlab, R, Minitab, or Excel in order to conduct statistical analyses on collected data.
Strong mathematical skills with basic statistics knowledge.
Knowledge of GMP, ISO, and FDA rules and regulations, failure Mode Effects Analysis (FMEA) and Statistical Process Control (SPC)
Experience working on the development of diagnostic devices under design control processes is highly desirable.
Experience in project management fundamentals.
Experience working with biological samples in a medical device development environment
Knowledge of Polymerase Chain Reaction (PCR) or other biological applications of fluorescence-based techniques..
Experience with integration of instrument, consumables, reagents, and software components (e.g. systems integration) is a plus.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.