Overview
On Site
140k - 160k
Full Time
Skills
Collaboration
Electrical Engineering
Biology
Mentorship
Leadership
SolidWorks
Modeling
Drawing
Design Review
FMEA
Risk Assessment
Management
Testing
Manufacturing
Regulatory Compliance
Medical Devices
FOCUS
Product Development
Mechanical Engineering
3D CAD
Creo
Design Documentation
Verification And Validation
Design For Manufacturability
GD&T
Quality Management
ISO 13485
Risk Management
ISO 9000
Communication
Job Details
Our client, an innovative diagnostic medical device company, is seeking a Lead Mechanical Engineer to join their team. This individual will play a critical role in leading the design, development, and refinement of mechanical systems for next-generation diagnostic products. The company is committed to transforming point-of-care diagnostics and is looking for someone who thrives in a collaborative, fast-paced environment.
This is an excellent opportunity for an experienced mechanical engineer who is passionate about improving patient outcomes through cutting-edge technology.
Key Responsibilities
This is an excellent opportunity for an experienced mechanical engineer who is passionate about improving patient outcomes through cutting-edge technology.
Key Responsibilities
- Lead the mechanical design and development of diagnostic instruments and consumables from concept through commercialization.
- Collaborate closely with cross-functional teams including electrical engineering, software, biology, manufacturing, and quality to ensure product integration and performance.
- Provide technical mentorship and leadership to junior mechanical engineers and designers.
- Execute detailed mechanical design using CAD tools (e.g., SolidWorks), including modeling, drawing creation, and tolerance analysis.
- Drive design reviews, FMEA processes, and risk assessments to ensure robust product development.
- Oversee prototype builds, testing, and iterations to refine product performance and manufacturability.
- Support transfer to manufacturing and scale-up, including vendor engagement and design-for-manufacturing (DFM) improvements.
- Ensure compliance with FDA, ISO, and other applicable regulatory standards for medical device development.
- Bachelor's or Master's degree in Mechanical Engineering or related field.
- 7+ years of experience in the medical device industry, with a strong focus on product development and commercialization.
- Proven experience leading mechanical design projects from concept through launch.
- Strong background in the development of diagnostic instruments, disposable components, or fluidics systems is highly desirable.
- Proficient in 3D CAD software (Creo) and design documentation practices.
- Experience with design verification and validation (V&V), DFM, and GD&T.
- Familiarity with quality systems (ISO 13485), risk management (ISO 14971), and regulatory requirements for Class II or Class III devices is a plus.
- Excellent communication skills and the ability to work collaboratively in a team-oriented environment.
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