Mechanical Engineer

Actalent Miami, Florida
mechanical engineer design technical medical mechanical devices engineer engineering orthopedic medical devices analysis technical writing
October 1, 2022
Actalent
Miami, Florida
FULL_TIME

DESCRIPTION:

We are seeking a Mechanical Engineer in our Research and Development Department. The ideal candidate will be able to successfully manage multiple projects, an outstanding technical leader, demonstrate innovative designs, work with vendors, and help drive technical projects from concept to completion. They must have a passion for design and engineering and be dedicated to getting the job done. The scope of work will include cutting edge upper extremity orthopedic product design. This role will include working with surgeons and engineers during the design control process and working with operations and quality during the release phase. Primary Responsibilities Lead the design and development of complex medical devices by leveraging knowledge and hands-on experience in the development of upper extremity orthopedic devices. Generate user requirements, perform risk analysis, conduct verification & validation, design transfer, and market release. Work with surgeons, sales and marketing, and contract manufacturers to ensure project success. Assist cross-functional teams acting as the subject matter expert as needed. Provide technical leadership and mentor less experienced engineers.

SKILLS:

mechanical, engineer, technical writing, solidworks, medical device, DFM, FEA, Ortho*, iso13485, CFR 820, Implant, Design Controls

TOP SKILLS DETAILS:

mechanical, engineer, technical writing, solidworks, medical device, DFM, FEA, Ortho*, iso13485, CFR 820, Implant, Design Controls

ADDITIONAL SKILLS & QUALIFICATIONS:

Qualification BS/MS in Mechanical Engineering with a minimum of 2 years of experience. Advanced knowledge in SolidWorks. Working experience with finite element analysis (FEA) preferred. Understanding of Design-for-Manufacturability (DFM) Understanding of FDA 21CFR and International Regulatory requirements (ISO 13485, ISO14971) associated with medical devices. Excellent technical writing skills a must. Travel may be required approximately 10% Working experience with finite element analysis (FEA) and machining experience preferred Plus: Direct experience in medical device industry, orthopedics preferred. Working knowledge of Statistics preferred. Understanding of FDA 21CFR and International Regulatory requirements (ISO 13485, ISO14971) associated with orthopedic medical devices.

EXPERIENCE LEVEL:

Expert Level

ABOUT ACTALENT:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.



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