Full Time Position
Competitive Salary + Benefits + Relocation Assistance
Interview Travel Reimbursed – Yes
Job ID- 3061
We are a global medical technology company that is focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Staff Mechanical Engineer will be expected to interpret requirements and rationalize the design choices with the multi-disciplinary team, leverage quantitative approaches and knowledge of both mechanical design and manufacturing considerations, design, assemble and evaluate prototype models in order to assess technical feasibility of various solutions.
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering or similar. (MS or PhD) in Mechanical Engineering, Biomedical Engineering or similar preferred.
- 5+ years of post-educational professional experience in Medical Device Design.
- Experience using PLM and CRM systems.
- Experience with design best practices, including advanced tolerance design, and design for reliability.
- Extensive experience solving problems and well versed in critical thinking.
- Must have Systems and requirements engineering experience.
- Design for Six Sigma, Design for Manufacturability training / experience.
- Experience with injection molded plastics and design of high-volume disposables.
- Experience as mechanical lead in the development of medical disposable devices.
- Proficiency with basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies.
- Expertise in common risk management techniques (FMEA, FTA, ETA).
- Experience in modeling, simulations and sensitivity analyses.
- Experience in development using cross-functional teams ideally in a healthcare, medical technology or life sciences area.
- Working knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO 14971 and IEC 60601 and collateral standards.
- Ability to challenge the status quo in light of development efficiency while maintaining a robust design and design standards.
Contact: Bhavna Mittal
Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package.