Senior Design Engineer, Product Development
Company: Gateway Recruiting, INC.
Location: Santa Clara
Posted on: March 13, 2023
- Formulates and implements research and development programs,
policies, and procedures required to support profitable
- Interfaces with appropriate internal and external resources to
ensure intellectual property are appropriately protected.
- Provides technical assistance for diagnosing design and
manufacturing quality problems.
- Guides development and documentation of test plan protocols,
standard operating procedures, specifications, and test
- Participates in review boards for intellectual property, CAPA,
complaints, business unit planning, and others as necessary.
- Reviews and provides functional approval for project and
quality system documentation.
- Tracks and forecasts divisional and product and technology
- Support all Divisional initiatives as identified by divisional
management and in support of Quality Management Systems (QMS),
Environmental Management Systems (EMS), and other regulatory
- Complies with U.S. Food and Drug Administration (FDA)
regulations, other regulatory requirements, Company policies,
operating procedures, processes, and task assignments. Maintains
positive and cooperative communications and collaboration with all
levels of employees, customers, contractors, and vendors.
- Experience working in a broader enterprise/cross-division
business unit model is preferred.
- Work in a highly matrixed and geographically diverse business
- Work within a team and as an individual contributor in a
fast-paced, changing environment.
- Leverage and/or engage others to accomplish projects.
- Strong verbal and written communication with the ability to
effectively communicate at multiple levels in the
- Multitasks, prioritizes, and meets deadlines in a timely
- Strong organizational and follow-up skills, as well as
attention to detail.
- Ability to travel approximately 10%, including internationally.
- Bachelor's Degree in a technical field, preferably mechanical,
chemical, biomedical, industrial, or quality engineering; materials
science, biochemistry, chemistry, physics, or management.
- Minimum of 5 years relevant experience.
- Solidworks or similar CAD programs.
- Medical Device experience. -PREFERRED QUALIFICATIONS:
- A Master's Degree in a technical or business field is
- Understands FDA Regulations. -Powered by JazzHR
Keywords: Gateway Recruiting, INC., Santa Clara , Senior Design Engineer, Product Development, Engineering , Santa Clara, California
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