Address
Form of work Responsibilities:
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering or similar
- Minimum of 3 years of post-educational professional experience
- Fluent in CAD modeling using Solidworks or ProE
- Graduate degree in Mechanical Engineering, Biomedical Engineering or similar
- 5 years of post-educational experience in Medical Device Design
- Experience with design best practices, including advanced tolerance design, design for reliability, and design for reusability.
- Design for Six Sigma, Design for Manufacturability training / experience
- Nice to have - Experience with injection molded plastics and design of high-volume disposables
- Experience as mechanical lead in the development of high volume disposables
- 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.
- Working knowledge of regulatory standards applicable to design of medical devices, including eu MDR, FDA QSR, ISO 13845, ISO 14971 and IEC 60601 and collateral standards
- Lead Design control deliverable
- Ability to lead discussions cross-functionally
- Self-directed and ability to learn
- Perform/supervise testing
- Create Design Verification plans/protocols
- Perform/supervise testing
- Hybrid flexibility 2-3 days a week
Requirements:
- Excellent written & verbal communication skills
- Minimal direction with the ability to learn and adapt quickly to new technologies and trends
- Strong organization and coordination skills
- Demonstrated customer focus, track record of innovation and publication
- Must be comfortable making practical assumptions with engineering justifications, where needed.
- Ability to work independently.
- Ability to work under pressure and time constraints.
- Effective interpersonal and collaborative skills.
