ccessful candidate will be technical lead in his/her respective consumables design and development, complex problem solving, and technology evaluation and deployment to enable efficient manufacturing for sustainable, large-scale production (>30MM units annually). The successful candidate shall use their knowledge of mechanical design, GD&T practices, materials and injection molding processes to effectively (with minimal guidance) engineer custom solutions, develop DFM feedback, improve current designs and interface with vendors. He/she shall use the experience in consumables manufacturing to transition designs from the Concept phase through Design and Development and into Production. Through these phase gates of product development and/or new product introduction, the successful candidate will apply DFMEA, DFM, and CAE tools to develop robust component designs that encourage manufacturing efficiencies for injection molding 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; must be able to interface well with other engineers, scientists, vendors, and operations personnel. There are no direct reports to this position.
ESSENTIAL JOB RESPONSIBILITIES:
- Enhance existing consumables parts production, with an emphasis on refining part specifications, improving manufacturability, and maintaining integral product quality and performance.
- Design, test, and validate new consumable designs in collaboration with multi-disciplined engineering teams.
- Manage component specifications in Quality Management System (QMS) and ensure those specifications are applicable to product function and Cepheid's Quality Policy.
- Use CAD modeling, prototyping, molding simulation CAE data, and hands-on lab testing to develop and enhance part attributes, mold concepts, and mold design details.
- Proactively identify risks in the design of parts, molds, and methods associated with consumables 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, injection molding tool design, and contract manufacturing of consumables components.
- Develop high standards for all Consumables 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 consumables parts performance.
- Coordinate Engineering testing, first article inspections, and qualification activities.
- Mentor others to utilize advanced inspection technologies, statistical methods, process data, DOE, and root cause analyses 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 consumables throughout a product lifecycle.
- Work with Qualification Team to go through molding process development and complete injection tooling press and mold IOQ.
- 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 consumables parts designs and compliance with specifications or intended use.
- Work with Manufacturing Engineering to create initial BOMs and updated models as required.
TRAINING RESPONSIBILITIES: (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
Education and Experience (in years):
- Bachelor's degree in field with 5+ years of related work experience OR
- Master's degree in field with 3+ years of related work experience OR
- Doctoral degree in field with 0-2 years of related work experience.
Knowledge and skills:
- BS in Mechanical, Plastics, Manufacturing Engineering or equivalent combination of education and experience to perform at this level.
- Working knowledge of GMP, ISO, and FDA rules and regulatory requirements for medical device industry.
- Working experience with designs for large-scale injection molding.
- Working experience in tolerance stack-up analysis in assembly.
- Working knowledge of plastics material properties, molding process development, and tooling design.
- Working experience with creating drawings, BOMs, product specifications, and engineering drawings.
- Proficiency with SolidWorks, MiniTab, and Microsoft Office applications.
- Ability to prioritize and manage multiple, concurrent projects in a fast paced environment.
- Excellent verbal and written communication skills.
- Extensive knowledge of plastics material properties, molding process development, and tooling design.
- Extensive knowledge in GD&T and metrology
- Experience in statistical tolerance stack-up analysis
- Experience in computer-aided engineering analysis software (i.e. Sigmetrix CETOL, Autodesk Moldflow, ANSYS, etc.)