Ophthalmic Manufacturing Engineer: Process & Automation

ZEISS Group; Doylestown (Bucks County); On-site; USD 77,000 - 96,000; Full time

Benefits offered by this job

Performance bonus

Medical plans

Retirement savings plan

Paid time off

Job summary

ZEISS Group in the United States is seeking a Manufacturing Engineer located in New Britain, PA to design, simulate, build, test and document production tools and processes for ophthalmic surgery equipment.

You will collaborate with production sites across the US, improve processes, manage documentation, CAPA investigations, and train production staff while ensuring compliance with ISO 13485 and 21 CFR Part 820.

Qualifications

• Bachelor’s or Master’s in a relevant engineering field.
• Experience in medical devices or regulated industry preferred.
• Familiar with ISO 13485 and FDA regulations.
• Proficient in 2D/3D CAD tools (AutoCAD/SolidWorks).

Responsibilities

• Provide engineering support to US production sites.
• Update work instructions, drawings and test procedures.
• Develop tooling, fixtures and CAPA investigations.
• Support investigation of nonconformances and CAPA.
• Analyze processes and implement improvements.
• Manage preventative maintenance system.
• Test and validate machines (FAT/SAT/IQOQPQ).
• Document processes and maintenance plans.
• Solve electro/mechanical machine problems.
• Train production staff and inspectors.

Skills

Analytical skills

Team player

Communication

Hands on attitude

Problem solving

Ability to manage ambiguity

Strong organizational skills

Process improvement mindset

Education

BSc./MSc. in mechatronics, mechanical engineering, product design, test- process- or industrial engineering

Tools

AutoCAD

SolidWorks

Minitab

Office

Outlook

Job description

ZEISS Group in the United States is seeking a Manufacturing Engineer located in New Britain, PA to design, simulate, build, test and document production tools and processes for ophthalmic surgery equipment.

You will collaborate with production sites across the US, improve processes, manage documentation, CAPA investigations, and train production staff while ensuring compliance with ISO 13485 and 21 CFR Part 820.