Sr. Mechanical Engineer

San Jose, CA

Posted: 03/25/2019 Employment Type: Direct Hire Industry: IT Job Number: JOS000008236

This company is an ambitious, well-funded, and fast-paced early stage biotech startup. Driven by a belief that disease diagnosis should be quick, accurate, and accessible to all, this company is developing a novel diagnostic device platform that aims to redefine the way an infectious disease is tested and treated.  
We have a talented team of researchers, biologists, designers, operations and administrative resources team. If you are passionate about making a difference, thrive on tackling challenging problems, and want to join a collaborative ownership team that will change the world of healthcare, please consider the following Senior Mechanical/Mechanical Engineer opportunity: 
- Design of parts and modules comprising of a molecular test product. 
- Transfer designs to manufacture and assist in creating production methods and processes. 
- Select component suppliers and/or production suppliers to produce the product. 
- Write design requirements and specifications. 
- Write test protocols. 
- Execution of test protocols to produce evidence of part or module performance. 
- Analyze or create engineering models to guide design of parts or modules. 
- Research through concept development, prototype, or analysis candidate designs or methods for future products. 
- Other duties as assigned 
Minimum Requirements: 
- BS, MS in Mechanical Engineering, Physics, Bio-engineering or equivalent combination of education and industry experience 
- Greater than 4 years of experience commercial experience in a product oriented company. 
- Must have strong cross-functional communication skills. 
- Strong product, process, and automation engineering skills in consumer, medical and diagnostic products. 
- Expertise with disposables design and testing for fluid dispensing. 
- Strong injection molding design expertise, tooling, process and vendor development/management.  
- Best candidates will showcase familiarity with all aspects of difficult molding. 
- Design for Manufacturability (DFM) experience with process and automation/machine design. 
- SolidWorks CAD expert level. And SolidWorks PDM 
- Design and process controls - leading FMEA, HA, V&V efforts and using DOE, GD&T, Gage R&R 
- Experience in the medical device industry with emphasis on Current Good Manufacturing Practices (CGMP) per 21CFR820, ISO 13485 quality management system / regulatory requirements and ISO 9001:2008 
- Experience in the selection of medical grade resins including TPE & silicone. 
- Experience in an environment using PCR techniques. 
- Expertise in Microfluidics. 
The company is an affirmative action and equal employment opportunity employer and does not discriminate on the basis of race, gender, color, ancestry, religious creed/religion, national origin, sex, disability, genetic information/characteristics, medical condition, age, marital status, sexual orientation and protected veteran status or any other status protected by law. 

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