TX: Sr. Mechanical Engineer (Temp to Perm) (232456)

Life Sciences & Technology | Validation

Job Description 

The Sr. Mechanical Engineer performs and owns all aspects of new and existing medical device product design, drawing, development, costing, manufacturability, optimization, Engineering confidence testing, packaging, and design control documentation with adherence to all applicable standards from conception to launch.
• Establishes requirements and assures product conformance through appropriate inspection and test activities.
• Review product / system requirements and create new concepts for mechanical design of new product or enhance the design of existing product as required and own the development process from concept to launch.
• Develop mechanical design to product specifications in compliance with company standards, procedures, specifications, and codes.
• Design and develop tolerance stack analysis using 3D modeling and statistical tools. Support the design control process with necessary documentation like DFMEA, Impact analysis.
• Prepares layout and detailed drawings including all required fits, dimensions, section views and parts lists/BOM
• Conduct complex FEA, as needed, to ascertain the design conforms to the functional and safety requirements.
• Conduct complex DFMEA and develop design controls to mitigate the product level risk.
• Investigate new materials and incorporate complex DFM and DFA principles into product design
• Perform mold flow analysis to ascertain the part design accommodates all injection molding process requirements.
• Lead design reviews for systems robustness and Design for Manufacture and Assembly (DFMA)
• Perform root cause analysis to resolve design anomalies and incorporate design changes as necessary
• Work with external vendors to build prototypes and evaluate performance. Perform ECT testing together with the V&V team, guide the test team as an SME

Required Skills 

• Medical device design experience is required.
• SolidWorks and FEA. Mold flow analysis is an advantage
• GD & T, Detailed drawings, Tolerance analysis
• Ability to implement DFM and DFA principles into product design and conduct risk analysis
• Knowledge of standard laboratory test methods for mechanical functional parameters
• Ability to perform root cause analysis using both experimental and statistical analyses
• Experience with plastics and injection molding

TX: Sr. Mechanical Engineer (Temp to Perm) (232456)


About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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