Senior Mechanical R&D Engineer for CTI

Location: Remote - USA NV

Remote Type: Onsite

Time Type: Full time

Job Description

About Us:

How many companies can say they’ve been in business for over 179 years?!

Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles ever-changing environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments like Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 46,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!

Location/Region: This position is located in our facility in Reno, NV.

What’s the role?

Join ZEISS and help shape the future of cataract surgery through cutting-edge medical device innovation. In this role, you will contribute to the design and development of advanced ophthalmic technologies, including next-generation surgical solutions such as the ZEISS miLOOP and ZEISS MICOR 700. Working alongside cross-functional teams, you’ll lead mechanical design efforts from concept through production, helping deliver innovative solutions that improve surgical precision and patient outcomes worldwide.

You’ll bring strong SolidWorks expertise, hands-on product development experience, and a passion for solving complex engineering challenges in a fast-paced medical device environment.

Sound Interesting?

Here’s what you’ll do:

• 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.
• Expertise in injection molding - Molded part design; gate locations, slides, lifters, parting lines, knit lines,  ejector pins/plates, and draft
• Create and release engineering documentation: MI’s BOM’s Drawings, Test Protocols/Reports and all associated risk documents within the Design History File etc..
• Highly experienced in writing DCO’s/ECO’s and engineering justifications defending design changes.
• 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.
• Sample population statistical analysis for Confidence & Reliability
• Firm understanding of differences between attribute and variables data .
• 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

Do you qualify?

Education / Professional Certification:

• BS degree in Mechanical Engineering or equivalent experience in mechanical and system design.

Experience:

• Minimum of five (5) years’ experience.

Knowledge / Skills / Other characteristics:

• Excellent proficiency in SolidWorks CAD design.
• 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 or at a minimum ISO 9001
• 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

WORKING ENVIRONMENT:

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

We have amazing benefits to support you as an employee at ZEISS!

• Medical
• Vision
• Dental
• 401k Matching
• Employee Assistance Programs
• Paid time off including vacation, personal, and sick days
• The list goes on!

The above is intended to describe the general content of and requirements for this job. It is not to be construed as an exhaustive statement of requirements, duties, or responsibilities. The Company reserves the right to interpret, amend, or otherwise modify, in whole or in part, any job description at any time, at its sole discretion.

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).