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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in mechanical design and project coordination for medical devices, with a strong understanding of regulatory requirements and design history file development. Proficient in SolidWorks and Microsoft Office Suite, with experience in research and prototyping.
Highest-signal resume keywords
Mechanical Design SkillsSolidWorks CAD ProficiencyMedical Device Research ExperienceU.S. FDA GMP KnowledgeISO and ASTM Testing Methods
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Mechanical DesignData GatheringProtocol PreparationDesign History File DevelopmentTest FixturingInjection MoldingPlastic ExtrusionPlastic Part AssemblyRisk ManagementValidation
Soft Skills
CollaborationProfessional ResponsibilityProject CoordinationTimely Execution
Tools & Technologies
SolidWorksMicrosoft Office SuiteProject Management Software
Industry Keywords
Medical Device DesignRegulatory ComplianceDesign ModificationsResearch InitiativesExploratory Work
Tech Stack
Tools & technologiesAssembly
About the role
Key responsibilities & impact- Supports research and project initiatives by working with clinicians, researchers, and vendors which may involve travel to sites within the United States.
- Gathers data on current state of the art, practices, policies, etc. to support unmet needs development.
- Prepares protocols and coordinates execution for exploratory work, research, and prototyping for various medical devices and components.
- Assists with the development of Design History Files.
- Supports multiple projects and ensures they are completed in a timely manner.
- Applies mechanical design skills to the creation and/or modification of existing medical device designs, test fixturing and manufacturing equipment.
- Helps generate design ideas for new products as well as solutions to existing products when modifications are requested.
- Demonstrates professional responsibility by cooperating with other personnel to achieve departmental goals and objectives.
Requirements
What you’ll need- Possession of a bachelor's degree in engineering.
- One year of medical device or other related research experience minimum is preferred.
- Experience in using SolidWorks CAD (design/drafting) program.
- Proficient using Microsoft Office Suite (Project, Word, Excel, PowerPoint)
- Background with injection molding, plastic extrusion and plastic part assembly process and methods desired.
- Experience with U.S. FDA GMP and ISO requirements for design, risk management, and validation preferred.
- ISO and ASTM testing methods for medical devices preferred.
- An understanding of regulations pertaining to medical device design and design modifications preferred.
Benefits
Comp & perks- Expected Travel: Up to 10%
