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Manufacturing Engineer
Villalba, Puerto RicoDevelop Validations Documents (Master Validation Plans/Reports, Test Method Validations, IQ, OQ and/or PQ, CSV related documents), Execute Validations in assigned Manufacturing Areas, and generate Reports. Document and execute IQ for label printing, Implement Manufacturing processes changes through CCB. Able to implement EU MDR requirements (such as PIC card implementation, Manufacturing/PFMEA, FAI, manuals and new pins implementation
/ FW Configuration changes and other required activity per EU MDR requirements). Develop and/or revise PPM or DOTM as required. Support during submission documents review as applicable.
Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
1. Some experience in process validation , test method validation, CSV, handling of manufacturing process changes implementation (at packaging and/or manufacturing process flow).
2. Responsible, able to learn fast and adapts to continues changes in project schedule priorities as required. Able to coordinate and manage activities with multiple functions, able to apply problem solving techniques (critical thinking skills) to move roadblock without impact project schedule activities
3. Teamwork oriented, good communication skills, results oriented
Education Required: Bachelor degree in engineering
Years’ Experience Required: Minimum of two years preferred with some experience, intermediate position. Willing to evaluate good potential candidates at entry level
/ FW Configuration changes and other required activity per EU MDR requirements). Develop and/or revise PPM or DOTM as required. Support during submission documents review as applicable.
Responsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
1. Some experience in process validation , test method validation, CSV, handling of manufacturing process changes implementation (at packaging and/or manufacturing process flow).
2. Responsible, able to learn fast and adapts to continues changes in project schedule priorities as required. Able to coordinate and manage activities with multiple functions, able to apply problem solving techniques (critical thinking skills) to move roadblock without impact project schedule activities
3. Teamwork oriented, good communication skills, results oriented
Education Required: Bachelor degree in engineering
Years’ Experience Required: Minimum of two years preferred with some experience, intermediate position. Willing to evaluate good potential candidates at entry level