Senior Mechanical Engineer
2 weeks ago
At Mindlance, we are seeking a highly skilled Engineer III to join our team in the development of combination products and medical devices.
Job Summary:The Engineer III will work under technical supervision on project teams to support the development of combination products and medical devices. The successful candidate will contribute to manufacturing transfers and investigations, supplier-driven design changes, and product enhancements.
Key Responsibilities:- Perform documentation analysis and prepare technical transfer documentation
- Create technical documentation for products in development
- Prepare design change documentation for existing products
- Design and execute laboratory studies supporting product development and investigations
- Demonstrate skills in creating testing protocols and writing technical reports
- Troubleshoot experiments and instrumentation
- Learn and understand new experimental techniques
- Place data in proper scientific context by consulting and citing relevant literature
- Demonstrate technical proficiency in medical device performance characterization
- Understand and adhere to corporate standards regarding code of conduct, safety, medical device design controls, and GxP compliance
- Proficient in technical transfers and design control principles for medical devices
- Proficient with documentation management systems
- Able to work in a regulated environment
- Able to work in a laboratory environment with a focus on electro-mechanical testing
- Familiar with CAD, design principles, GDT, tolerance stack analysis, tool room environment, metrology, and CMM principles
- Familiar with lab environment, safety practices, and Electronic Notebook handling
- Applies basic computer skills in support of data analysis
- Applies technical writing skills to produce technical reports and documents
- Bachelor's Degree or equivalent education in Biomedical, Mechanical, Chemical Engineering, Materials Science, or related field with 5+ years of experience
- Master's Degree or equivalent education in Biomedical, Mechanical, Chemical Engineering, Materials Science, or related field with 3+ years of experience
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
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