What are the responsibilities and job description for the Senior Research And Development Engineer position at Real Staffing?
Senior R&D Engineer
Note : We do not hire C2C
Additional position details from the manager are outlined below :
Must have :
TMV (Test Method Validation)
Design Verification
Experience working with fixtures (line machinery)
Top skill sets required
Development and testing for Phase 2 & Phase 3 stages.
Creation and testing of characterization protocols.
Generation and testing of design verification protocols.
Development and validation of test methods.
Development of fixtures.
Analysis of technical specifications and requirements.
Design modifications and translations into specifications / requirements.
Testing and qualification of new components.
Main responsibilities / day-to-day activities
Review and analyze current testing to determine if additional testing is needed.
Generate testing data to support the testing strategy.
Develop and validate test methods used to generate test data.
Possibly review technical specifications and requirement documents.
Potentially modify current designs to align with newer product technology / requirements.
Possibly translate new requirements to suppliers..
T arget years of experience
8-10 years, requiring someone independent and experienced.
Responsibilities may include the following and other duties as assigned :
Understanding the requirements of cross-functional internal customers.
Broad application and understanding of technical principles, theories, and concepts in the field.
Participation in preclinical evaluations.
Responsible for a subset of product design.
Development of product specifications, test methods, and equipment; execution of tolerance analysis.
Creation, review, and approval of protocols / reports.
Interpretation of test results.
Working knowledge of DRM and statistics.
Responsible for subsystems of designs or smaller designs in their entirety.
Completion of tasks associated with the area of responsibility within the assigned schedule.
Solid understanding of regulatory indications and requirements, such as IDE, 510k, PMAs, and contribution to assigned sections of submission documents.
Working knowledge of the internal quality system (e.g., SOPs, DOPs), external quality standards, and statistical methods.
Experience in design characterization and design selection.
Preferred Qualifications :
Experience with medical device-based products, processes, and technologies.
Experience in the medical device / pharmaceutical or other regulated industries.
Experience in design characterization and design selection.
Experience with SolidWorks or AutoCAD.
Proven experience executing product changes regulated by design control and applying the product development process to derivative product lines.
Mechanical design experience, including modeling for devices and fixtures.
Prototyping of devices and fixtures through 3D printing and / or machining; catheter device experience.
Experience in device design verification testing and test development.
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