- Bachelor's Degree
- Master's Degree
- Mechanical Engineering Experience
Work as a member of a project team to develop products from concept phase through launch using design control procedures.
Develop and write specifications for components/systems, product, processes, and packaging/labeling.
Design new products/processes using appropriate software tools.
Support suataining product development activities on released products.
Provide technical analysis on mechanical engineering design and implementation aspects within project teams.
Troubleshoot technical problems that arise in the implementation of designs.
Contribute to and execute engineering schedules and plans.
Instruct technical support staff on engineering test and build requirements.
Identify and quantify critical features and benefits that maximize product functionality and usability at minimal cost.
Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines, product specifications, and corporate quality standards.
Manage reliability, durability, and life cycle requirements.
Design and develop prototypes for first article review.
Integrate DFSS tools (i.e., CPM, noise and functional diagrams, reliability assessment and validation) in product development.
Write engineering test protocols for testing of component parts and integrated systems.
Execute key technical project activities such as design verification testing, sterilization validation testing, cleaning and disinfection validation testing, reprocessing testing, ISO 10993 related biocompatibility testing, shelf life testing, packaging validation testing, and ISTA shipping validation testing.
Prepare cost and time estimates for engineering and project schedules.
Demonstrate knowledge and understanding of Good Manufacturing Practices and other applicable medical device standards such as ISO 13485, ISO 14971.
Stay informed about applicable new rules, regulations, and standards.
Travel as needed to domestic and international vendor sites, company locations, and clinical settings.
Prepare weekly progress reports on projects.
Prepare verbal presentations for various company meetings.
Provide extensive engineering documentation with proper use of laboratory notebooks, spreadsheets and graphical summary of results in support of development, intellectual property applications, regulatory FDA filings, and verification and validation protocols.
Education: Required: Bachelor’s degree in Mechanical Engineering. Master’s degree preferred.
Experience: Minimum 3-5 years of experience in product development with an emphasis on various aspects of mechanical engineering design and development.
Experience with CAD tools (Creo, Solidworks) is desirable.
Experience with FEA tools would be a plus.
Experience with sterilization validation testing, cleaning and disinfection validation testing, reprocessing testing, ISO 10993 related biocompatibility testing, shelf life testing, packaging validation testing, and ISTA shipping validation testing would be beneficial.
Experience using document control system (Agile)
Experience resolving CAPAs
Experience working in a multifunctional team
Experience working in a medical device environment would be a benefit, but not essential.