BSc./MSc. in mechatronics, mechanical engineering, product design, test-process or industrial engineering.
1-5 years experience in medical device or other regulated industry preferred.
Familiarity with ISO 13485 and 21 CFR Part 820 regulations and standards.
Experience in design and construction of process aids and tools.
Proficiency in 2D and 3D CAD software, ideally AutoCAD and SolidWorks.
Responsibilities
Provide engineering support to all US production sites.
Update manufacturing work instructions, technical drawings, and test procedures.
Develop and implement process improvements, new tooling, and fixtures.
Investigate nonconformances and CAPA with engineering expertise.
Analyze existing manufacturing processes for improvements. H
Manage the Preventative Maintenance (PM) system for equipment.
Perform testing and validation of machines and associated processes.
Benefits
3 weeks of accrued vacation.
10 sick days annually (prorated for new hires).
10 paid US holidays.
90% health insurance premiums paid by the company.
Dental and vision coverage included.
401k plan with company match available.
Paid short-term and long-term life insurance.
Full Job Description
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)
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; 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
Your ZEISS Recruiting Team: Debra Ann Rybolt, Jo Anne Mittelman
About Carl Zeiss Meditec, Inc
Carl Zeiss Meditec, Inc. is a leading provider of medical devices for ophthalmology and neurosurgery. The company was founded in 2002 and is headquartered in Dublin, California. Carl Zeiss Meditec's products include surgical microscopes, diagnostic systems, and intraocular lenses, among others. The company is committed to improving patient outcomes through the use of innovative technology and has a strong track record of delivering high-quality products to its customers. Carl Zeiss Meditec operates in over 50 countries worldwide and has a global workforce of over 3,500 employees.
