Senior Mechanical Designer

Role: Senior Mechanical Designer

Location: This role is a fully onsite position located at our Reno, Nevada facility.

Senior Mechanical Designer will assist in the development of design approaches and perform detailed mechanical design of subsystems of new or improved products.

Essential functions and responsibilities:

• Proficient in SolidWorks: Efficient and well-organized parametric modelling ability.
• Creation and implementation of design strategies to meet functional specifications and cost constraints for new and existing products.
• Write and execute DOE’s (design of experiments) to determine optimal design solutions. 
• Tolerance stack analysis for assemblies and critical components.
• Create and release engineering documentation: MI’s BOM’s Drawings, Test Protocols/Reports and all associated risk documents within the Design History File etc..
• Manage supplier relationships: All associated device and fixture components necessary for successful program completion. 
• Leading interactions with production team to implement design changes for manufacturability. 
• Evaluation of fabricated and purchased parts for conformance to design requirements.
• Responsible for organizing, executing and completing Design Reviews for products and Fixturing.
• Drive continuous improvement within the R&D group.
• Drive complaint and NCMR investigations through closer.
• Assist in regulatory submissions to FDA and other regulatory authorities outside United States.
• Direct the efforts of junior level Engineers. Check completed drawings for capturing critical dimensions design intent, clarity, completeness and conformity to best practices. 
• Assemble and test prototypes.
• Execute and manage Design Verification & Validation testing. 
• Interpret and analyze Engineering data to solve challenging design problems anticipating solutions and implementing corrective action. 
• Traveling to surgical sites training and advising doctors on use of devices within product portfolio. 

Additional Responsibilities:

• May be required to provide input to activities related to managing the risks associated with the use of medical devices

Qualifications:

• BS degree in Mechanical Engineering or equivalent experience in mechanical and system design.
• Excellent proficiency in SolidWorks CAD design.
• Minimum of five (5) years’ experience.
• Excellent knowledge of mechanical principles, including stress, injection molded polymer selection, fluidics, kinematics, thermal analysis and will be experienced in creating complex, functional assemblies in SolidWorks.
• Excellent knowledge of multi-axis machining, molded part design, mold design, die-extrusions and forming, and custom tool design is necessary.
• Deep understanding of medical device regulations (FDA 21 CFR Part 820, ISO 13485.
• Strong written and verbal communication skills.
• Supervisory and motivational skills required.
• Ability to identify problems and take corrective measures to solve them quickly and efficiently

Special Demands:

• Travel – as needed 
• Physical requirements: standing, sitting, walking, stairs, light lifting, manual dexterity, operating computers.   Ability to tolerate direct exposure to IPA, adhesives, part cleaning solutions and other materials common to medical device production. 

Working Environment:

• Open plan space indoor office
• Warehouse and lab-indoors
• Fully on-site five days per week 

Job descriptions change from time to time. The Company retains the right at its sole discretion to modify, delete, or add to any of the information contained in this document. Changes will be discussed with the employee.

Your ZEISS Recruiting Team:

Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).