We are a technical and engineering staffing agency that has found its niche in recruiting Medical Device Engineers. We are currently seeking an experienced Medical Device Engineer for our client, a leading innovator in the field of diagnostic instruments, providing cutting-edge solutions for hospitals and clinical laboratories worldwide. Their product portfolio encompasses Hemostasis, Acute Care, Autoimmunity diagnostics, and Original Equipment Manufacturing services.
Typical Duties and Responsibilities
- Lead the full hardware development lifecycle for medical devices, including prototyping, testing, and manufacturing.
- Utilize expertise in plastic mold design and plastic mold flow analysis to optimize designs for manufacturability.
- Collaborate cross-functionally with R&D, Manufacturing, and Quality teams to develop and improve processes for new and existing products.
- Ensure compliance with medical device regulations and standards, and assist with product validation and verification processes.
- Evaluate and select appropriate components and technologies, balancing performance and manufacturing requirements.
- Troubleshoot hardware issues, identify root causes, and implement effective solutions to enhance device performance.
- Stay abreast of industry trends and emerging technologies to drive innovation within the company.
Education
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
Required Skills and Experience
- Expertise in plastic mold design and plastic mold flow analysis.
- Solid experience in leading end-to-end hardware development lifecycle.
- Strong understanding of Design for Manufacturability (DFM) principles.
- Proficiency in SolidWorks Data Management.
- Experience working in cross-functional teams, including R&D, Manufacturing, and Quality.
- Knowledge of medical device regulations and standards.
- Familiarity with product validation and verification processes.
- Ability to troubleshoot hardware issues and implement effective solutions.
Preferred Qualifications
- Experience with Finite Element Analysis (FEA), Six Sigma, Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), and Minitab.
- Proficiency in Arduino and Microsoft Office Suite (Word, PowerPoint, Excel).
- A track record of driving innovation in medical device hardware.
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
