Manufacturing Engineer – Ophthalmic Medical Devices

ZEISS Group; Doylestown (Bucks County); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Vacation

Health insurance

401k plan

Bonus program

Job summary

DORC, part of ZEISS Group, seeks a Manufacturing Engineer to support US production sites in New Britain, PA. You will design, test, and improve production tools and processes for ophthalmic surgical devices, ensuring compliance with ISO 13485 and 21 CFR Part 820.

You will update instructions and documentation, manage CAPA, and collaborate with suppliers, with a hands-on, analytical approach to improve yield and efficiency.

Qualifications

• 1-5 years experience in medical device or regulated industry.
• Regulations/standards: ISO 13485, 21 CFR Part 820.
• Design/construction of process aids.
• 2D/3D CAD use (AutoCAD, SolidWorks).
• Process data analysis with Minitab or similar.

Responsibilities

• Provide engineering support to all US production sites.
• Update manufacturing work instructions, drawings, labeling, and test procedures.
• Develop process improvements; generate tooling and fixtures.
• Investigate nonconformances and CAPA.
• Analyze manufacturing processes and implement improvements.
• Manage Preventative Maintenance (PM) system.
• Test and validate machines (FAT, SAT, IQOQPQ).
• Maintain process documentation and SOPS.

Skills

English proficiency

Analytical skills

Communication

Team player

Problem solving

Organization

Education

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

Tools

AutoCAD

SolidWorks

Minitab

Office/Outlook

Job description

DORC, part of ZEISS Group, seeks a Manufacturing Engineer to support US production sites in New Britain, PA. You will design, test, and improve production tools and processes for ophthalmic surgical devices, ensuring compliance with ISO 13485 and 21 CFR Part 820.

You will update instructions and documentation, manage CAPA, and collaborate with suppliers, with a hands-on, analytical approach to improve yield and efficiency.