Manufacturing Engineer

Carl Zeiss, Inc.; New Britain (CT); 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

Carl Zeiss, Inc. is seeking a Manufacturing Engineer to support ophthalmic production sites in the US, focusing on design, simulation, testing and documentation of production tools for eye surgery devices.

You will improve processes, develop tooling, and ensure compliance with safety and regulatory standards. Qualified candidates have a strong Mechatronics/Mechanical background (BSc/MSc), CAD experience, and 1–5 years in a regulated medical-device setting.

Qualifications

• BSc./MSc. in mechatronics, mechanical engineering, product design, test-, process- or industrial engineering or similar.
• 1–5 years in medical device or regulated industry is preferred.
• Familiar with ISO 13485 and 21 CFR Part 820 is a plus.
• Strong problem solving and documentation skills.

Responsibilities

• Provide engineering support to all US production sites.
• Update work instructions, drawings, labeling and test procedures.
• Develop process improvements and new tooling/fixtures.
• Test and validate machines and processes (FAT/SAT/IQOQPQ).
• Create risk analyses (PFMEA) and support CAPA investigations.

Skills

Mechatronics

Mechanical engineering

CAD (2D/3D)

Minitab

Lean principles

PFMEA

Education

BSc./MSc. in mechatronics

Mechanical engineering

Product design

Test/Process/Industrial engineering

Tools

AutoCAD

SolidWorks

Minitab

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.

Education and Experience

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

Preferred Qualifications

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).

Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.

Join us today. Inspire people tomorrow.

Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.