Manufacturing Engineer

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?

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).