How Will You Make an Impact?
For this role, the manufacturing engineer is involved with the installation and monitoring of manufacturing equipment and machinery for the Single-Use Technology manufacturing plant. The task is to ensure that SUT products and/or medical devices are produced in the most cost-effective and time-efficient way. Most importantly, ensure the products must be manufactured to the highest possible standard and adhere strictly to industry guidelines such as Good Manufacturing Practice (GMP) and internal quality control protocols.
What will you do?
Typical day-to-day responsibilities of a manufacturing engineer for the SUT manufacturing facility include the installation and evaluation of manufacturing processes and equipment. However, the role also regularly extends to:
- Acquiring new equipment
- Design and procure materials, fixtures and other tooling required for new products on existing equipment.
- Identifying and optimizing material and process flows.
- Analyzing manufacturing processes to then identify, develop and implement improvement projects
- Expected to engage across multiple global production sites to share and implement best manufacturing and procedural practices.
- Solving issues with manufacturing processes
- Carrying out root-cause analysis
- Preparing manufacturing-related documentations
- Provide frontline engineering support to production activities.
How will you get here?
- Bachelor’s Degree in engineering or Technical field or 5 years minimum experience in manufacturing/process engineering or another closely related field or an equivalent combination of education and experience.
- Capability in SolidWorks CAD software.
- Ability to respond quickly to production issues as needed
- Mechanical, Manufacturing or Technical Engineering degree or equivalent experience
- Minimum 10 years experience in Process/Manufacturing Engineering in a production environment
- Experience with various statistical analysis tools and methods
- Excellent communication, interpersonal and interdepartmental coordination skills
- Past experience in BioPharmaceutical industry with cGMP, FDA and ISO13485 guidelines
- Past experience with Lean Manufacturing methods and philosophies
- Self motivated and mastery of problem solving skills using investigative tools (5 Why, Fishbone, Fault Tree Analysis, 8D, etc.)
- Experience with engineering standards, testing, SPC and FMEAs
- Excellent technical writing skills
- Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Project, Visio)
- Proficiency in DOE and FEA and associated software tools.
- Understanding of ISO9001, ISO13485, ISO14971 and 21CFR Part 820 requirements.
- Experience in manufacturing processes and an understanding of various manufacturing regulatory guidelines for the life science industry would be useful.
- Good mechanic knowledge is also needed to understand manufacturing equipment and machinery.
- Knowledge, Skills, Abilities
- Able to read mechanical drawings and if needed revise drawings using Solidworks
- Support New Product Introduction (NPI) and product transfers from R&D and Contract Manufacturer (CM).
- Provide Sustaining Engineering support such as improving manufacturing First Pass Yield (FPY), support manufacturing process improvement and evaluating alternate parts for End of Life (EOL) replacement.
- Plan and ensure smooth start up of new product transfers to local manufacturing operation. Provide product sustaining support after completion of manufacturing transfer.
- Plan and execute engineering activities to improve manufacturing operation key performance indicators such as quality, waste, efficiency and efficacy.
- Plan and execute cost reduction, process enhancement, material and engineering evaluation project to achieve cost and operation effectiveness.
- Plan and execute validation activities to support NPI and product transfer to local manufacturing operation.
- Maintain and ensure systems and procedures are in compliance with ISO, Regulatory and housekeeping requirements.
- Plan and execute activities with other cross-function to ensure common goals are met.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.