Senior Manufacturing Engineer for CTI

ZEISS Group; Carson City (NV); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical

Vision

Dental

401k Matching

Employee Assistance Programs

Paid time off

The list goes on!

Job summary

ZEISS Group in Reno, NV is seeking a Senior Mechanical/Manufacturing Engineer to lead cross‑functional projects, drive regulatory compliance, and advance next‑generation cataract surgery devices. You will own design reviews, implement process improvements, and mentor teams in a fast‑paced manufacturing environment.

We expect 7+ years in regulated engineering, strong GMP/ISO13485 knowledge, and Lean Six Sigma expertise.

Qualifications

• Bachelor's or Master's degree in Mechanical Engineering preferred.
• 7+ years of engineering experience with leadership in cross-functional teams.
• Strong GMP and ISO 13485 knowledge and experience.
• Lean Six Sigma training and project leadership.
• Experience in regulated manufacturing environments.

Responsibilities

• Lead and oversee multiple concurrent projects with cross-functional teams.
• Facilitate design reviews to drive innovation and regulatory compliance.
• Improve manufacturing efficiency and product quality through process improvements.
• Promote lean manufacturing and operational excellence.
• Develop and maintain device documentation, BOMs, and manufacturing instructions.
• Lead qualification and validation activities for processes and equipment.
• Develop detailed project schedules and monitor milestones.
• Manage yields and throughput with data-driven decisions.

Skills

Leadership

Project Management

Cross-functional Collaboration

GMP ISO13485 knowledge

Lean Six Sigma

Clean room

Mentoring

Education

Bachelor's or Master's in Mechanical Engineering

Certifications in leadership or medical device design

Tools

SolidWorks CAD

Job description

About Us

How many companies can say they’ve been in business for over 180 years?!

Here at ZEISS, we certainly can! As pioneers of science, ZEISS handles ever-changing environments in a fast-paced world, meeting it with cutting edge 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.

About Us

How many companies can say they’ve been in business for over 180 years?!

Here at ZEISS, we certainly can! As pioneers of science, ZEISS handles ever-changing environments in a fast-paced world, meeting it with cutting edge 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. This role is ideal for engineers who thrive on ownership, technical depth, and cross‑functional leadership. In this role, you will contribute to the next‑generation surgical solutions such as the ZEISS miLOOP and ZEISS MICOR. Join a rare engineering environment where innovation moves fast and scale matters. The Reno team combines the best of two worlds: a startup mindset empowered by the resources, funding and stability of ZEISS.

You will serve as the project leader and chief technical authority for new product development and sustaining engineering initiatives, collaborating closely with R&D, Operations, and Quality Management teams.

Sound Interesting?

Here’s What You’ll Do

• Strategically manage and prioritize multiple concurrent projects and objectives, ensuring optimal allocation of resources and alignment with organizational goals.
• Lead and facilitate design reviews, providing expert guidance across cross‑functional teams (R&D, QA, OPS) to drive innovation and ensure compliance with regulatory standards.
• Identify, champion, and implement process and procedural improvements to enhance manufacturing efficiency, product quality, and regulatory compliance.
• Promote and embed lean manufacturing principles throughout the organization, driving continuous improvement and operational excellence.
• Oversee the creation and maintenance of comprehensive product documentation, including component specifications, BOMs, CAD models and drawings, manufacturing instructions, and lot history records.
• Direct the development, maintenance, and improvement of manufacturing equipment, tooling, and fixturing, ensuring reliability and scalability.
• Author, execute, and supervise test protocols, analyze test data, and prepare detailed test reports to support validation and verification activities.
• Lead process validation and equipment qualification efforts, ensuring all manufacturing processes meet regulatory and quality requirements.
• Develop and maintain detailed project schedules, ensuring timely completion of milestones and deliverables.
• Monitor manufacturing production yield and throughput; proactively identify issues and implement solutions to improve performance and minimize disruptions.
• Establish, monitor, and evaluate key performance indicators for manufacturing processes, driving data‑driven decision‑making and continuous improvement.

Additional Responsibilities

• Provide leadership and guidance to the assembly team, fostering a culture of quality, consistent manufacturing output, and high yields.
• Travel periodically as required to support project deliverables, supplier audits, and organizational needs.
• Initiate and oversee Document Change Orders and Nonconformance Material Reports activity; actively participate in Corrective and Preventive Actions as required.

Do you qualify?

Education / Professional Certification

• Bachelor's or Master’s degree in Mechanical Engineering preferred; certifications in leadership or medical device design are highly valued.

Experience

• At least 7 years of engineering experience, ideally in regulated industries, with proven leadership in cross‑functional teams and projects.

Knowledge / Skills / Other Characteristics

• Strong interpersonal and collaborative skills; ability to mentor teams and communicate effectively; expert problem solver.
• Skilled in SolidWorks CAD for complex fixture and tooling design, overseeing reviews and implementation across projects.
• Deep knowledge of materials and processing methods; adept at optimizing for performance, manufacturability, and compliance.
• Advanced training in GMP and ISO 13485; experienced in maintaining quality systems and driving improvement.
• Lean Six Sigma expert with a history of leading successful process improvements and team training.
• Proactive in identifying and solving technical and operational challenges, ensuring effective corrective actions across departments.
• Significant clean room (CER) operations experience, including staff training and compliance leadership.
• Physical requirements: Able to perform basic movements and tasks; comfortable with exposure to manufacturing materials.

Working Environment

• Open plan space indoor office
• Warehouse, CER 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
• 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.

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).