Manufacturing Engineer

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

Dutch Ophthalmic USA and Peregrine Surgical are part of DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery.

Every single day our employees ensure that eye surgeons all over the world enjoy the use of innovative ophthalmic devices, instruments, and liquids. DORC uses cutting-edge technology, works closely with innovative surgeons, and thrives to make a difference. Ophthalmologists worldwide use our advanced Ophthalmic surgery unit EVA to take care of their patients to help them see again.

DORC is a ZEISS company, an internationally leading technology enterprise that develops, manufactures and sells highly innovative products and solutions in a variety of business fields, such as medical technology. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities.

Location/Region:

This position will be located in New Britain, PA.

What’s the role?

The Manufacturing engineer is responsible for activities that include but are not limited to design, simulation, building, test and documentation to develop and/or maintain/ improve production tools and test equipment for the manufacturing of products for ophthalmic surgery. This also includes the development and improvement of production processes and related documentation. All activities need to be carried out in conformity with international regulations, safety and performance standards as applicable.

Here’s What You’ll Do

• Provide engineering support to all production sites within the US
• Update current manufacturing work instructions, drawings, package labeling, and test procedures.
• Develop process improvements, generate new tooling and fixtures
• Provide engineering support and expertise in the investigation of nonconformances and CAPA
• Analyze existing manufacturing processes, identify and implement process improvements.
• Manage the Preventative Maintenance (PM) system
• Testing and validating machines with associated processes (FAT, SAT, IQOQPQ)
• Process documentation and production documents (e.g. Process requirements, SOPS, maintenance plans)
• Analytically driven, solving (electro)mechanical machine problems
• Performing machine and process tests and analyzing process data (DOE)
• Collaboration with external suppliers, system integrators and automation Companies.
• Preparing risk analyses of assembly and test processes (PFMEA)
• Training and supervising production personnel and final inspectors in production
• Continuous improvement of yield and efficiency.
• BSc./MSc. in mechatronics, mechanical engineering, product design, test- process- or industrial engineering or similar.

• Preferred 1-5 years experience in medical device or other regulated industry.
• Regulations and standards in Medical Devices (e.g. ISO 13485, 21 CFR Part 820)
• Design and construction of process aids
• Standard IT skills (Office, Outlook etc.)
• Problem solving techniques (e.g. RCA, DMAIC, 5 Why, Ishikawa, or other)
• Reporting & documentation skills according to GDP
• Experience with 2D and 3D CAD (ideally AutoCAD and Solid Works)
• Process data analysis and specific software (e.g. Minitab)
• Lean principles, ideally green belt or higher
• Knowledge of production techniques and market available solutions and technologies as well as certification requirements of manufacturing equipment
• Risk management principles, Process FMEA
• English: full professional proficiency
• Team player, trustworthy
• Ability to communicate transparently & efficiently
• Ability to manage ambiguity, goal conflicts
• “Hands on” and “Can do” attitude
• Actively live and promote DORC Corporate Values
• Strong analytical skills combined with the capability to see “the big picture”
• Well organized, goal oriented, high sense of accountability.

What does Peregrine Surgical have to offer you?

Peregrine Surgical, LLC is part of the Dutch Ophthalmic Research Center - a Zeiss Company.

The annual pay range for this position is $76,900 - $96,100.

The pay offered for this role may be influenced by factors such as job location, scope of role, qualifications, education, experience, & complexity/specialization/scarcity of talent.

This position is eligible for a Performance Bonus.

ZEISS also offers robust benefits, including medical plans, retirement savings plan and paid time off.

Your ZEISS Recruiting Team

Debra Ann Rybolt, Jo Anne Mittelman

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).