Manufacturing Engineer

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

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.

Sound Interesting?

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?

Benefits

Peregrine Surgical, LLC is part of the Dutch Ophthalmic Research Center - a Zeiss Company; we value our employees and provide top tier benefits. You can expect the following:

• 3 weeks of vacation (accrued)
• 10 sick days annually (prorated for new hires)
• 10 US holidays
• 90% of Health Insurance premiums paid by the company.
• Dental & Vision coverage
• 401k plan with company match
• Paid short term, long term & basic life insurance paid by the company.
• Bonus program

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).