What are the responsibilities and job description for the Senior Mechanical Engineer position at QPS Employment Group?
We are seeking a Hybrid Mechanical Engineer to join an innovative and lean startup developing cutting-edge high-frequency energy-based solutions for medical applications. This position is ideal for a hands-on, resourceful engineer with a background in medical device design who thrives in a fast-paced, collaborative environment.
Key Responsibilities :
- Product Design :
- Develop and design hardware for system components, ensuring adherence to stringent medical device standards.
- Write and refine detailed product requirements, conduct design analysis, and perform failure mode analysis.
- Execute verification testing and provide solutions to complex, constrained design challenges.
- Prototyping and Testing :
- Build prototypes, support clinical and bench testing, and implement process improvements.
- Collaborate with vendors and subject-matter experts to optimize product functionality and manufacturability.
- Cross-Functional Collaboration :
- Work closely with system engineers, electrical engineers, clinicians, and regulatory teams.
- Coordinate with outside suppliers to manage requirements and maintain timelines.
- Documentation :
- Develop Design History File (DHF) deliverables, including test protocols, design inputs, and risk analyses.
- Support FDA Design Control processes and ensure compliance with Quality Systems.
Qualifications : Experience :
Technical Skills :
Soft Skills :
What We Offer :
Salary : $110,000 - $150,000
