Job ID 21000BUG
Available Openings 1
PURPOSE AND SCOPE:
Assists with developing new or modified existing process, defines processing equipment requirements and specifications, and reviews processing techniques and methods applied in the manufacturing process. Works with product development teams to concurrently evaluate and create new or update existing designs for the manufacturability, reliability, and testability of new products based on modern manufacturing requirements and guidelines. Assesses set-up process flow and coordinate design requirement with manufacturing engineer to ensure compatibility of processing methods.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Under close supervision, utilizes established procedures to perform routine assigned Manufacturing Engineering tasks.
- Learns to use professional concepts. Applies company policies and procedures to resolve routine issues.
- Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
- Plans, develops, implements, and maintains modern manufacturing methods, operation sequence, processes, and operations for new and existing products in a regulated medical device environment.
- Evaluates, selects, and orders equipment that is most appropriate (including ergonomic/safety considerations) and cost effective for the manufacture of company products. Oversees the installation, modification, upgrade, and maintenance of this equipment.
- Maintains current records on equipment manufacturers' technical notices, upgrades and safety issues.
- Studies equipment performance/reliability and establishes programs and solutions for increasing uptime and for equipment problems that affect the manufacturing process.
- Defines and writes preventative maintenance schedules.
- Develops and oversees execution of Process Validation protocols including detailed IQ, OQ, and PQ activities.
- Establishes and assists with implementing appropriate manufacturing controls based on Process Validation results including modern concepts like Process FMEA's, Capability Indices, Control Plans, etc.
- Plans and assists with implementing equipment and process modifications to improve production efficiencies, manufacturing techniques, and production yields for existing products.
- Partners with Quality Assurance to ensure appropriate manufacture/fabrication of parts, components, sub-assemblies, and final assemblies within the supply base.
- Ensures the effective use of materials, equipment, and personnel in producing quality products at minimum costs with calculated/minimized patient risk.
- Represents Manufacturing Engineering in product design and development to ensure processes and designs are compatible (design for manufacture and is integrated in the Design Transfer Process).
- Develops/supports systems (i.e. MES, etc.) for traceability and recording of manufacturing data.
- Capable of producing relevant reports to show effectiveness of process improvements and production line status.
- Contributes to root cause analysis efforts to implement permanent corrective/preventive actions for nonconforming material on the production line and as required for the CAPA process, and participate with personnel from other functions where Manufacturing Engineering knowledge is required for problem solving.
- Completes projects and documentation as assigned by the department manager or designate within identified time frame.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Bachelor's Degree required.
EXPERIENCE AND REQUIRED SKILLS:
- 0 – 2 years of related experience.
- Well-versed in protocol development/execution and efficiency improvement tools.
- Effective in written and verbal communications.
- Good understanding of software management tools.
- Knowledge of computer data base system.
- Ability to read scientific and technical journals, functional reports and legal documents.
- Ability to write reports, business correspondence and procedure manuals.
- Ability to effectively present information to upper management and other groups.
- Ability to apply logical and scientific critical thinking to a wide range of intellectual and practical problems.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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