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Sr. R&D Mechanical Engineer

Ledgent Technology Milpitas Full-Time
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JOB TITLE:        Senior Mechanical R&D Engineer
**Must have extensive medical device experience, ideally with  patient contact devices

ESSENTIAL FUNCTION:
1.    Responsible for the creation and/or translation of customer/management requirements into measurable product specifications.  Additionally, assists with the application of collateral requirements for such products or subsystems (e.g. ANSI/AAMI TIR 28, ISO 10993 and 11135, ASME pressure vessel requirements, IEC 60601 requirements, etc.).
2.    Lead the effort for determining product and major sub-system performance requirements, identifying the necessary resources, and preparing development plans that accomplish product development tasks.
3.    Responsible for the complete design and development of major subsystems or significant portions of the product.  Considers the technical requirements for design activities, including loading (mechanical {stress, pneumatic, frictional, etc.}, electrical {electric potential, current carrying capacity, field influence}), user, environmental, performance (stress-strain limitations and requirements, cyclic stress, charge-discharge cycles, etc.), external (biocompatibility, shipping), and implements solutions that address these requirements.
4.    Assisting with completion of development activities required for product marketing including packaging design and testing, labeling, sterilization and biocompatibility validation protocols and execution, materials selection, and development of verification and validation protocols.
5.    Coordinate and perform design verification and validation activities for the product and major subsystems.
6.    Assist with and/or prepare regulatory agency documentation to support approvals (e.g. summary test reports, Risk Management documents, etc.).
7.    Perform or assist with transfer into manufacturing, including equipment and tooling and fixture design and fabrication, process development, operator training and process validation.
8.    Lead the effort to create and/or assist with manufacturing documentation, including Device Master Records, Manufacturing Procedures, Quality Instructions, and Test Procedures.  Review them for completeness and effectiveness and suggest improvements if not adequate to ensure desired output.  Monitor output to ensure the design requirements are realized.  Intercede when the results are not as expected to ensure the team only releases high quality products that meet the specifications and regulatory requirements.
9.    Perform and/or assist with training of manufacturing and quality engineers, assemblers, technicians, and other support personnel.
10.    Create and/or augment documentation in Design History File.
11.    Maintain records of ideas, developments, and test results in a bound notebook that is periodically verified.
12.    Assist with preparation of documentation to support proprietary information development.

EDUCATION AND EXPERIENCE:

Typically requires a Bachelors degree in Mechanical Engineering. A MS degree is preferred.  At least 8-10 years of experience in a Research & Development environment.  Medical Device experience is required.

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
JOB TITLE: Senior Mechanical R&D Engineer •*Must have extensive medical device experience, ideally with patient contact devices ESSENTIAL FUNCTION: 1. Responsible for the creation and/or translation of customer/management requirements into measurable product specifications. Additionally, assists with the application of collateral requirements for such products or subsystems (e.g. ANSI/AAMI TIR 28, ISO 10993 and 11135, ASME pressure vessel requirements, IEC 60601 requirements, etc.). 2. Lead the effort for determining product and major sub-system performance requirements, identifying the necessary resources, and preparing development plans that accomplish product development tasks. 3. Responsible for the complete design and development of major subsystems or significant portions of the product. Considers the technical requirements for design activities, including loading (mechanical {stress, pneumatic, frictional, etc.}, electrical {electric potential, current carrying capacity, field influence}), user, environmental, performance (stress-strain limitations and requirements, cyclic stress, charge-discharge cycles, etc.), external (biocompatibility, shipping), and implements solutions that address these requirements. 4. Assisting with completion of development activities required for product marketing including packaging design and testing, labeling, sterilization and biocompatibility validation protocols and execution, materials selection, and development of verification and validation protocols. 5. Coordinate and perform design verification and validation activities for the product and major subsystems. 6. Assist with and/or prepare regulatory agency documentation to support approvals (e.g. summary test reports, Risk Management documents, etc.). 7. Perform or assist with transfer into manufacturing, including equipment and tooling and fixture design and fabrication, process development, operator training and process validation. 8. Lead the effort to create and/or assist with manufacturing documentation, including Device Master Records, Manufacturing Procedures, Quality Instructions, and Test Procedures. Review them for completeness and effectiveness and suggest improvements if not adequate to ensure desired output. Monitor output to ensure the design requirements are realized. Intercede when the results are not as expected to ensure the team only releases high quality products that meet the specifications and regulatory requirements. 9. Perform and/or assist with training of manufacturing and quality engineers, assemblers, technicians, and other support personnel. 10. Create and/or augment documentation in Design History File. 11. Maintain records of ideas, developments, and test results in a bound notebook that is periodically verified. 12. Assist with preparation of documentation to support proprietary information development. EDUCATION AND EXPERIENCE: Typically requires a Bachelors degree in Mechanical Engineering. A MS degree is preferred. At least 8-10 years of experience in a Research & Development environment. Medical Device experience is required.

Skills required

Engineering
Manufacturing
Research
Prototype (Manufacturing)
Mechanical Engineering
Process Development
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Job ID: JO-1907-63559

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