Manufacturing Engineer – Process Improvement & RCA Lead

Extremity-Care; Franklin (WI); On-site; USD 75,000 - 110,000; Full time

Job summary

Extremity-Care Manufacturing Engineer position seeks a technically skilled engineer to support the production floor, improve processes, and develop cost-efficient manufacturing concepts. You will train operators, mentor technicians, and involve maintenance in solving process, material, mold, tooling, and equipment issues using systematic troubleshooting.

Key duties include participating in FMEA, Kaizen events, and process validation.

Qualifications

• Bachelor degree in engineering with a focus on polymer science or related field.
• 3 years of manufacturing experience in medical devices preferred.
• Experience with root cause analysis and lean methodologies.

Responsibilities

• Improve existing processes and develop cost-effective manufacturing concepts.
• Train operators, mentor technicians, and engage maintenance to resolve problems.
• Participate in FMEA, PFD, Kaizen, and cross-functional events.
• Execute IQ/OQ/PQ validation protocols and document results.
• Close CAPAs timely and manage project status with timelines and action items.

Skills

Communication

Teamwork

Root cause analysis

Education

Bachelor of Science in Engineering (Polymer Science)

Six Sigma Green or Black Belt

Tools

Lean Manufacturing

Job description

The Manufacturing Engineer is primarily responsible for providing technical assistance and engineering support to the manufacturing group. Additionally, improve existing processes, develop new and cost-effective manufacturing concepts as well as train production operators, mentor process technicians and engage maintenance personnel in resolving process, material, mold, tooling and equipment problems using systematic methods of troubleshooting, root cause analysis, and irreversible corrective action implementation.

Duties & Responsibilities:

• Improve existing processes, develop new and cost-effective manufacturing concepts, lead scrap reduction teams through lean methodologies, and actively participate in value improvement projects.
• Provide technical assistance, process development and engineering support to the manufacturing floor to include extruding, molding, assembly, and packaging areas to ensure timely delivery of product while meeting customer expectations on cost and quality.
  
• Train production operators, mentor process technicians and engage maintenance personnel in resolving process, material, mold, tooling, and equipment problems using systematic methods of troubleshooting, root cause analysis, and irreversible corrective action implementation.
• Support flawless launch activities through active participation in FMEA, PFD, part and tool design reviews, Kaizen, and other cross-functional team events.
• Execute validation and qualification (IQ/OQ/PQ) protocols for new product, equipment, tooling, and processes. Follow SOP on re-validation of existing equipment, tooling, and processes.
• Work closely with Project Engineers in developing processes that meet customer expectations on cost, quality, and delivery of new product development.
• Document lessons learned and report status of all projects and assignments in a timely manner.
• Generate, update, and implement process documentation, including ECO’s, operator work instructions, manufacturing procedures, sample requests, process, inspection and troubleshooting guides.
• Close assigned CAPA’s in a timely manner.
• Complete project and report status in a timely manner. Utilize project management tools in establishing timelines, building action item lists, and completing milestones.
• Understand and follow the SOP’s pertaining to the specific area.
• Understand and follow the Work Instructions pertaining to the specific area.
• Maintain hazardous waste according to EH&S procedures.
• Other duties as assigned.
• Report to work in-person and start job duties on time for established shift.
• Complete required hours on assigned works shift to complete assigned responsibilities and duties.

Skills & Abilities:

• Excellent written and verbal communication and effective human interaction skills.
• Flexible to change and possess a high degree level of integrity and “can do attitude”.
  
• Willing to work in a team environment and contribute to group goals
  
• Ability to receive and provide instructions in a positive manner.
  
• Able to comprehend college algebra, college physics, basic chemistry, statistics, and unit conversion.
  
• Ability to secure and maintain a favorable background investigation and clearance.

Education & Experience:

• Bachelor of Science in Engineering with a focus on Polymer Science, or related field, preferred.
• 3 years' experience in manufacturing environment preferably in medical devices with hands on responsibility for processes, preferred; or equivalent combination of education and experience.
• Experience in thermoset or thermoplastics extrusion, molding and/or assembly process for medical devices is preferred.
• Experience with root cause analysis
• Six Sigma Green or Black Belt preferred
• Lean Manufacturing preferred

Physical Requirements:

The physical demands and work environment characteristics 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.

• This physical demand level for this job is considered medium with frequently lifting between 10-25 pounds and occasionally lifting 50 pounds. Exposure to lifting more than 50 pounds is rare (if ever).
• Frequently subject to sustained bending, using hands to finger or handle or touch, use foot/feet to operate machine with constant exposure to dynamic standing/sitting.
• Occasionally exposed to static standing/sitting, pushing/pulling(less than 50lb of force), floor to knuckle lift/lower (less than 50lbs), knuckle to shoulder lift/lower(less than 50lbs), shoulder to overhead lift/lower(less than 50lbs),climb/balance, stoop, kneel, crouch or crawl, reach above shoulders and repetitive bending or squatting.
  
• The following vision requirements apply: close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• Constantly exposed to working near moving mechanical parts with frequent exposure to risk of electrical shock.
• Occasionally exposed to wet humid conditions, working in high precarious places, fumes or airborne particles, extreme cold or heat, outdoor weather conditions or travel on company business.
• Rarely (if ever) be subject to toxic or caustic chemicals. The noise level is considered loud if near operating production equipment.
• Required to wear appropriate Personal Protective Equipment such as: safety glasses in the designated areas, hairnet/beard net, gloves when handling hot objects or solvents, jumpsuit, earplugs (when needed) on production floor.
• Constantly use hand/power tools and machine equipment, with frequent use of maintenance shop tools.
• Occasionally will use a PC with Microsoft Office products, manlift/elevator, forklift and pallet/hydraulic jacks.