What are the responsibilities and job description for the Manufacturing Engineer II position at IntePros?
Manufacturing Engineer II.
Onsite~
Top 3 technical skills that are required for the role:
Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs.
Completes activities of the change control policy and Corrective and
Preventive Action (CAPA) system in accordance with Medtronic Corporate CAPA system. Completes activities of Lean Sigma projects and process improvements.
Provides technical support to purchasing personnel and suppliers by interpreting product drawings, initiating the development of manufacturing drawings and resolving technical production problems.
Proactively Execute And Support Development Of Validation/qualifications Studies.
Determine strategy with appropriate teams and ensure that groups are involved early on in the needs of the engineering group.
Responsible for the investigation of change requests received in the Manufacturing Engineering department, their rejection or approval, development and implementation of any process changes and proper documentation of any such changes.
Working with the appropriate groups; maintains manufacturing process sheets for all machining, assembly, and finishing operations.
Makes appropriate changes in manufacturing methods, processes and Manufacturing Process Planning documentation when dictated by engineering drawing changes.
Documents all changes through the appropriate change control system. Coordinates entry of all master data for assigned product lines.
This may include Purchase Requests, Capital Appropriation Request, Inventory Approval Forms, Material Masters, Bills of Material, routings, production versions, work centers, and document information records.
Coordinates update of production order data as needed Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs.
Performs other duties as assigned. Working knowledge of industry standards and regulatory requirements (including but not limited to: ISO 13485, ISO 14971, MDD 93/42 EEC, PAL, CMDR, and 21 CFR Part 820).
Understands impact of compliance to the requirements and how it relates to their job, or is aware of resources available to them to assist with determining impact.
Strong communication skills, both oral and written Good interpersonal skills
Ability to work in a fast paced environment
Ability to work well under pressure and maintain positive, enthusiastic attitude Eagerness to learn and expand responsibilities
Ability to work effectively in a team environment and build strong working relationships. Willingness to participate in continuous improvement activities
Required
Bachelors Degree in Engineering discipline and at least 2 years of relevant experience providing direct manufacturing process support, OR Masters’ Degree and less than 2 years of relevant experience in a manufacturing environment providing direct manufacturing process support.
Years’ Experience Required: 2 years of relevant experience providing direct manufacturing process support
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 decision making.
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.
DR1
Onsite~
Top 3 technical skills that are required for the role:
- Experience with ERP systems – SAP
- Experience with EUMDR
- Experience with change control in Medical Device Quality System Education
- shop floor support for manufacturing methods and processes in machining, metal finishing and assembly operations for assigned product lines.
Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs.
Completes activities of the change control policy and Corrective and
Preventive Action (CAPA) system in accordance with Medtronic Corporate CAPA system. Completes activities of Lean Sigma projects and process improvements.
Provides technical support to purchasing personnel and suppliers by interpreting product drawings, initiating the development of manufacturing drawings and resolving technical production problems.
Proactively Execute And Support Development Of Validation/qualifications Studies.
Determine strategy with appropriate teams and ensure that groups are involved early on in the needs of the engineering group.
Responsible for the investigation of change requests received in the Manufacturing Engineering department, their rejection or approval, development and implementation of any process changes and proper documentation of any such changes.
Working with the appropriate groups; maintains manufacturing process sheets for all machining, assembly, and finishing operations.
Makes appropriate changes in manufacturing methods, processes and Manufacturing Process Planning documentation when dictated by engineering drawing changes.
Documents all changes through the appropriate change control system. Coordinates entry of all master data for assigned product lines.
This may include Purchase Requests, Capital Appropriation Request, Inventory Approval Forms, Material Masters, Bills of Material, routings, production versions, work centers, and document information records.
Coordinates update of production order data as needed Initiates improvements in current manufacturing methods and processes to improve part quality, schedule performance and to reduce manufacturing costs.
Performs other duties as assigned. Working knowledge of industry standards and regulatory requirements (including but not limited to: ISO 13485, ISO 14971, MDD 93/42 EEC, PAL, CMDR, and 21 CFR Part 820).
Understands impact of compliance to the requirements and how it relates to their job, or is aware of resources available to them to assist with determining impact.
Strong communication skills, both oral and written Good interpersonal skills
Ability to work in a fast paced environment
Ability to work well under pressure and maintain positive, enthusiastic attitude Eagerness to learn and expand responsibilities
Ability to work effectively in a team environment and build strong working relationships. Willingness to participate in continuous improvement activities
Required
Bachelors Degree in Engineering discipline and at least 2 years of relevant experience providing direct manufacturing process support, OR Masters’ Degree and less than 2 years of relevant experience in a manufacturing environment providing direct manufacturing process support.
Years’ Experience Required: 2 years of relevant experience providing direct manufacturing process support
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 decision making.
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.
DR1