Senior Mechanical R&D Engineer CTI

Job Overview

Join ZEISS and help shape the future of cataract surgery through cutting‑edge medical device innovation. This role focuses on designing and developing advanced ophthalmic technologies, such as the ZEISS miLOOP and ZEISS MICOR
700. You will lead mechanical design efforts from concept through production, working with cross‑functional teams to deliver solutions that improve surgical precision and patient outcomes worldwide.

• Proficient in Solid Works; efficient parametric modelling and creation of design strategies to meet functional specifications and cost constraints for new and existing products.
• Write and execute DOE’s to determine optimal design solutions.
• Perform 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.
• Write DCO’s/ECO’s and engineering justifications defending design changes.
• Manage supplier relationships for device and fixture components necessary for program completion.
• Lead interactions with production to implement design changes for manufacturability.
• Evaluate fabricated and purchased parts for conformance to design requirements.
• Organize, execute, and complete Design Reviews for products and fixturing.
• Drive continuous improvement within the R&D group.
• Investigate complaints and NCMRs through close‑out.
• Assist in regulatory submissions to FDA and other authorities outside the United States.
• Direct the efforts of junior level engineers.
• Check completed drawings for critical dimensions, design intent, clarity, completeness, and best‑practice conformity.
• Assemble and test prototypes.
• Execute and manage Design Verification & Validation testing.
• Perform sample population statistical analysis for confidence and reliability; interpret and analyse engineering data to solve design problems.
• Travel to surgical sites, train and advise doctors on device use.

• Provide input to activities related to managing risks associated with the use of medical devices.

• BS degree in Mechanical Engineering or equivalent experience in mechanical and system design.
• Minimum of five (5) years’ experience in medical device mechanical design.
• Excellent proficiency in Solid Works CAD design.
• Strong knowledge of mechanical principles: stress analysis, injection‑molded polymer selection, fluidics, kinematics, thermal analysis.
• Experience creating complex, functional assemblies in Solid Works.
• Knowledge of multi‑axis machining, molded part design, mold design, die‑extrusion, forming, and custom tool design.
• Deep understanding of medical device regulations, FDA 21
  
  CFR Part
  820, ISO
  13485 or ISO
  9001 at least.
• Strong written and verbal communication skills.
• Supervisory and motivational skills required; ability to identify problems and implement corrective actions quickly and efficiently.

• Open‑plan indoor office, warehouse and lab‑indoors.
• Fully on‑site five days per week.

• Medical, vision, dental.
• 401(k) matching.
• Employee Assistance Programs.
• Paid time off: vacation, personal, and sick days.

ZEISS provides Equal Employment Opportunity without unlawful regard to an applicant’s 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.