Job Description
You are responsible for
Lead mechanical development and product upgrades, along with the release of electro-mechanical modules to improve overall system quality, reliability, yield rates, and cost effectiveness.
Work with design partners/suppliers and lead product development activities from design concept to manufacturing release.
Work with a cross-functional team to ensure mechanical designs meet the needs of the internal and external customers.
Use SolidWorks to create and modify mechanical architectures, 3D designs, and 2D drawings.
Drive continuous improvement projects related to design implementation, manufacturing process, product quality and reliability.
To succeed in this role, you should have the following skills and experience
BSME or MSME from an accredited university.
0-2 years of experience in an engineering environment required, preferably in product development.
Specific knowledge in part design, datum schemes, tolerance analysis, GD&T, and design for manufacture.
Capable of evaluating design margins, tolerances, and reliability factors including, wear, materials strength, chemical compatibility, and compounding environmental effects.
Highly proficient in CAD, specific experience and proficiency in SolidWorks required.
Ability to troubleshoot nonconforming material and work with suppliers to improve part design.
Knowledge in part qualification and statistical process studies such as CP and CPK and be able to work with suppliers to improve part process capability.
Experience working with suppliers and design partners, including part/module development and resolving technical issues.
Knowledge of good design practices and experienced with DFMEA.
Demonstrated ability to effectively work with cross-functional stakeholders to ensure the design meets their expectations and needs, and that the needs/requirements are properly documented.
Strong technical writing/ documentation skills for regulated medical device design environment, including requirements definition.
Experience with document control systems (E-Matrix, Agile) and FDA/ISO regulated medical device design environment.