Mechanical Engineer-Medical Device
TITLE: Mechanical Engineer-Medical Device
DEPARTMENT: R&D Engineering Hardware
REPORTS TO: Design Engineering Manager
Responsibilities may include but will not be limited to the following as assigned:
- Daily brainstorming, concept development, prototype and test.
- Lead the design & release of a single use consumable which will support patient sample preparation, mixing, reagent flow, optical reading, & integration to the Genalyte POC Device.
- Develop products from concept through to manufacturing handoff while maintaining strict design documentation (DHF) and revision control.
- Drive rapid prototyping activities and select methods to evaluate product embodiments and efficiently inform design iterations.
- Prepare and execute Engineering Change Order packages, including drawings, documentation and supporting data.
- Co-ordinate across departments to write concise Product Requirement Documents for mechanical subsystems.
- Design and execute statistically based R&D experiments for product development.
- Root cause analysis of failures and technical problem solving.
- Work closely with vendors to develop parts, custom materials, fixtures and processes for high volume manufacturing.
- Maintain compliance with all applicable regulations, company policies, quality systems & procedures.
- Conduct design reviews and provide technical updates to program managers and functional area management.
- Perform other duties as assigned by supervisor.
- BS in Mechanical Engineering, MS preferred
- 10 + years of experience in related field
- Experience in design of instruments and consumables for the Medical Market
- Experience working in an FDA regulated environment
- Working knowledge of & strict demonstrated adherence to IEC 60601, ISO 13485, 21 CFR 820.30 standards
- Proficient with SolidWorks and PDM Works
- Working knowledge of GD & T and tolerance analysis
- Experience with high volume manufacturing processes such as injection molding, die cutting, laser bonding processes, surface treatment, is desired.
- Excellent oral and written communication skills
- Proficiency in MS Office, particularly data analysis using Excel
To apply please e-mail Cover Letter and CV to email@example.com.