Senior Diagnostic Consumables Engineer
The Cepheid Engineering team is seeking a 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 must be able to use their knowledge of mechanical design, materials, automation, and molding to engineer custom solutions, improve current designs, interface with vendors, and enable large scale manufacturing of consumables for the medical device industry. They will use their experience in consumables manufacturing to transition designs from the Concept phase through Design and Development and into Production. They will actively sustain and support re-qualifications of existing parts used in Production following tooling repairs and refurbishments. This is a hands-on position involving detailed design, testing, prototype fabrication and Engineering support of Production; must be able to interface well with other 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.
- Maintain and/or improve existing consumables parts production, with an emphasis on refining part specifications, improving manufacturability, and achieving cost reductions
- Use CAD modeling, prototyping, and hands-on lab testing to develop new designs to support and enhance consumable product line.
- Design, test, and validate new consumable designs in collaboration with diverse functional groups
- Actively participate in group meetings and be a technical point person in project teams.
- Use 3D CAD modeling, statistical analysis, and hands-on bench or line testing to characterize part attributes, process performance, and assembly characteristics.
- Proactively identify risks in the design of processes, equipment, and methods associated with consumables manufacturing and design quality into the equipment or process 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, equipment design, and analytical testing of consumables components.
- 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.
- 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.
- Ability to prioritize and manage multiple, concurrent projects in a fast-paced environment.
- Create custom fixtures and procedures for testing, inspection, or functional evaluation of consumables parts designs and compliance with specifications or intended use.
Required Knowledge, Skills, and Abilities
- BS in Engineering or equivalent combination of education and experience to perform at this level.
- 6 to 9 years of related work experience
- Excellent verbal and written communication skills.
- Must be proficient with standard Microsoft Office applications.
- Experience with inspection and measurement techniques
- Working knowledge of GMP, ISO, and FDA rules and regulations
- Experienced with creating drawings, BOMs, product specifications
- Quality Management System experience
- Basic knowledge of FMEA, SPC, and DOE
- Basic machining skills are a plus
- Industry experience in medical device consumables
- Experience with plastic injection molding and part design
- Experience in project management fundamentals
- Quality Management System experience
- Proficiency with SolidWorks.
- Experience with high volume manufacturing processes, including machining, extrusion, molding, ultrasonic welding.
- Experience with failure investigations and root cause failure analysis
- Physical Demands
- Ability to lift 10 - 20 lbs