Senior Manufacturing Engineer
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Job Details
JOB SUMMARY
Responsible for leading the assembly processes, including but not limited to harness assembly, bag making processes, bowl assembly and development of projects from the conceptual stage into production by functioning both as the technical lead and project manager. Maintains as effective preventive maintenance and CI program by developing activities with the in-house SME and vendors (e.g., planned maintenance, repairs, validations, transfer protocol, and process improvements). This position prepares annual maintenance, refurbishment, and the replacement budget for each process to ensure equipment and tooling remain in good working order to maximize their operational life and product quality parts.
Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Enter Responsibilities/Essential Duties
- Achieve cost savings by implementing cost reduction projects like cycle time improvement, jigs and fixtures, process automation, spare parts consolidation, defect reduction, etc.
- Direct, communicate, and manage projects including but not limited to design and engineering improvement of assembly processes, bonding, plastic welding, sealing, cutting, printing, coiling, leak testing, etc.
- Ensure each equipment, jigs and fixtures and tooling is up-to-date per equipment/ tooling master list and the respective drawings.
- Ensure all preventive maintenance and calibration requirements are fulfilled for all equipment and tooling.
- Integrate and align efforts from different sources by directing, supervising and/ or otherwise managing project team members and/ or contractors as required for successful CI project completion.
- Maintain production by supporting new products, processes, transfers, and existing production.
- Prepare annual repair and maintenance budget.
- Prepare documentation by writing and redacting scope of work, business case, user requirements, request for quotation, validation protocol and report.
- Provide any combination of equipment/ tools and component attributes to various functions within the organization for decision making processes.
- Provide, measure, monitor and analyse maintenance and engineering activities - leading the local computerized maintenance management system (CMMS) deployment.
- Research, investigate, test, and develop product transfer technology including manufacturing and testing equipment; and provides hands on troubleshooting to the mentioned technology.
- May be the project leader on Lean/Six Sigma initiatives and Cost Improvement Projects, 5S, Kaizen events.
- Responsible for driving multiple improvement programs through to implementation and following-up on the results achieved, including: Quality Monitoring and Actions, Production Efficiency, Improve Assembly Methods, Document and Implement Approved Changes.
- Ensure that production processes and systems as well as our product designs for both existing and new products produce the highest possible quality (consistency) and lowest possible cost.
SUPERVISORY RESPONSIBILITIES
Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, training and developing employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
QUALIFICATIONS
EDUCATION
Education Level
Education Details
Required/Preferred
Bachelor's Degree Engineering (Mechanical, Plastic, Molding or relevant course).Required
Master's Degree Engineering. Preferred
EXPERIENCE
Experience Level
Experience Details
Required/Preferred
+5 years
Experience and demonstrated expertise in relevant Engineering discipline and Project Management. Required
Required: Experience with ultrasonic welding.
Preferred: Knowledge of extrusion processes.
Experience in an FDA regulated industry.Required
Experience with computer based drawing and design programs, 3D training in Sold Works or Pro E. Preferred
Experience in medium/ high volume Medical, Pharmaceutical, Automotive or Food Industry. Preferred
Significant experience in Mechanical, Plastics/ Materials Engineering. Preferred
SKILLS
Skill Sets
Other Skills
Proficiency
Possesses strong technical aptitude
Experience in manufacturing process control and process validation requirements, including statistical tools.Advanced
Other
Computer literacy - highly proficient with computer program, e.g. Ms Excel, Power Point, Project and CAD software. Advanced
TRAINING/CERTIFICATIONS
List Each Training/Certification
Required/Preferred
- Experience with Six Sigma and Lean Manufacturing methodologies. Preferred
- Green Belt or Black Belt Certification. Preferred
PHYSICAL DEMANDS
A thorough completion of this section is needed for compliance with legal standards such as the Americans with Disabilities Act. The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Sit; use hands to finger, handle, or feel objects, tools, or controls.
Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
Lifting/moving up to 10 pounds.
Exposure to moving mechanical parts, vibration and/or moderate noise levels.
Exposure to hazardous chemicals or other materials.
Exposure to blood.
Other (please specify):
TRAVEL EXPECTATIONS
Minimal 0-10%
The above statements are intended to describe the general nature and level of work being performed by colleagues assigned to this position. They are not intended to be an exhaustive list of all responsibilities, duties, qualifications, or working conditions.