What are the responsibilities and job description for the Manufacturing Engineer position at MEDIcept Inc.?
Manufacturing Engineer - Contract - 40 hours Per Week/13 Weeks
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
Technical Skills:
- 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
Experience:
- Preferred 1-5 years experience in medical device or other regulated industry.
Travel:
Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected. This position supports all US production sites as needed and may involve scheduled visits to those sites. Up to 10% travel.
Qualifications
BSc./MSc. in mechatronics, mechanical engineering, product design, test- process- or industrial engineering or similar.