Sr Component Engineer
Posted on: June 6, 2021
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
- 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
- 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.
- Complete all assigned and required training satisfactorily and
Education and Experience (in years):
- Bachelor's degree in field with 5+ years of related work
- 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
- 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
- Ability to prioritize and handle multiple, concurrent
- Excellent verbal and written communication skills.
- Must be able to lift 50 lbs. Work may involve repetitive
- BS in Mechanical, Plastics, Manufacturing Engineering or
equivalent combination of work and education to perform at this
- Extensive knowledge of plastics, molding, and tooling
- 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
When you join us, you'll also be joining Danaher's global
organization, where 69,000 people wake up every day determined to
help our customers win. As an associate, you'll try new things,
work hard, and advance your skills with guidance from dedicated
leaders, all with the support of powerful Danaher Business System
tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to
equal opportunity regardless of race, color, national origin,
religion, sex, age, marital status, disability, veteran status,
sexual orientation, gender identity, or other characteristics
protected by law. We value diversity and the existence of
similarities and differences, both visible and not, found in our
workforce, workplace and throughout the markets we serve. Our
associates, customers and shareholders contribute unique and
different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided
reasonable accommodation to participate in the job application or
interview process, to perform crucial job functions, and to receive
other benefits and privileges of employment. Please contact us at
202.419.7762 or email@example.com to request
If you've ever wondered what's within you, there's no better
time to find out.
Keywords: Danaher, Sunnyvale , Sr Component Engineer, Other , Sunnyvale, California
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