Manufacturing Engineer

About 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.

Responsibilities

• 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

Requirements

• 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

Benefits

• 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