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Danaher Corporation Sr. Component Engineer in Sunnyvale, California

POSITION SUMMARY:

The successful candidate shall have in-depth knowledge and experience in part design and development of plastic consumables for medical device product(s) manufacturing); acts as resource and role model for colleagues with less experience. Use standard methodologies and knowledge of internal or external business issues to improve products. Technical lead in his/her respective consumables design, complex problem solving, and technology evaluation and deployment to enable efficient manufacturing for balanced, large-scale production (>30MM units annually). Utilize their knowledge of mechanical design, GD&T practices, materials and injection molding processes to optimal (with minimal mentorship) engineer custom solutions, develop DFM feedback, improve current designs and collaborate with vendors. He/she shall use the experience in consumables manufacturing to transition designs from the Concept phase through Development and into Production. Through these phase gates of product development and/or new product introduction, 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; Interface well with team members, scientists, vendors, and operations personnel.

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.

  • Lead 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, 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:

  • Complete all assigned and required training satisfactorily and on time

MINIMUM REQUIREMENTS:

Education and Experience (in years):

  • Bachelor’s degree in field with 5+ years of related work experience OR

  • Master’s degree with 3+ years of experience OR

  • Doctoral degree with 0-2 years’ experience.

Knowledge and skills:

  • Familiarity with GMP, ISO, and FDA rules and regulatory requirements for medical device industry.

  • Experience with designs for large-scale injection molding.

  • Working experience in tolerance stack-up analysis in assembly.

  • Solid understanding of plastics material properties, molding development, & 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 handle multiple, concurrent projects.

  • Excellent verbal and written communication skills.

Physical requirements/abilities:

  • Must be able to lift 50 lbs. Work may involve repetitive arm/wrist motions.

PREFERRED REQUIREMENTS:

  • BS in Mechanical, Plastics, Manufacturing Engineering or equivalent combination of work and education to perform at this level.

  • Extensive knowledge of plastics, molding, and tooling design.

  • Extensive knowledge in GD&T and metrology

  • Experience in statistical analysis

  • Experience in computer-aided engineering analysis software (i.e. Sigmetrix CETOL, Autodesk Moldflow, ANSYS, etc.)

The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.

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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

Operating Company: Cepheid

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