WillowWood
  • 19-Jul-2021 to 17-Sep-2021 (EST)
  • NPD
  • Mt Sterling, OH, USA
  • Full Time

Manufacturing Engineer

This position will focus on maintaining manufacturing equipment and processes to produce medical device products safely and efficiently meeting high quality standards. The position will be heavily involved in the day-to-day manufacturing needs to ensure equipment is running at optimal performance. Data driven solutions for continuous improvement of existing and new processes will be a focus. This will include identifying opportunities, building ROI based proposals, Planning and full implementation following safety, risk, and quality procedures. To effectively perform there will be a mix of analytical planning and direct hands-on implementation and troubleshooting required.

Primary Responsibilities

  • Ensure manufacturing equipment is running at optimal performance to meet safety, quality, and customer demand.
  • Work independently and with project teams to establish and achieve continuous improvement goals for manufacturing.
  • Preform analytical analysys to support and drive decisions needed to maintain current and future manufacturing process improvements.
  • Continuously identify and address efficiency shortcomings and bottlenecks in manufacturing.
  • Identify, secure, and implement updates to existing equipment and new equipment to support manufacturing in meeting demand.
  • Work with manufacturing managers, IT, and external sources to implement and maintain process tracking of materials, quality, and WIP.
  • Lead efforts to meet 13485 quality requirements for process implementation and validation. (IQ, OQ, PQ)
  • Lead efforts to do root cause analysis to identify improvement needs that address equipment efficiency and quality defect reduction.
  • Ensures change management procedures are followed and changes are properly validated and documented per the quality system.
  • Work with operations and purchasing to identify opportunities with raw material processing as well as testing and validation of new or changes to existing materials used in processes or products.
  • Participates in maintaining manufacturing documentation for products, drawings and specifications, inspection plans, bill of material and routing, assembly and packaging drawings, standard operating procedures (SOPs), work instructions, quality plans, equipment validation documents (IQ/OQ/PQ) and other required documents.
  • Ensure all documents are generated and in compliance with company quality system and customer requirements.
  • Participate in vendor assessments.
  • Participate in review of product reports and customer concerns.
  • Participate in Internal and external quality audits.
  • Select, monitor, and build control systems for automation.
  • Coordinate with external vendors and contractors to achieve improvement project objectives and goals.
  • Define specifications for new and existing equipment.
  • Assess existing equipment to identify safety concerns and make recommendations for upgrades.

Education and Experience

  • Bachelor's degree in Manufacturing, Industrial, or Mechanical Engineering Disciplines preferred
  • 2+ years of applied professional experience in process engineering or related manufacturing field.
  • Medical Device manufacturing experience, with understanding of ISO13485:2016 preferred
  • Lean Six Sigma green belt or higher preferred.

Essential Knowledge, Skills and Abilities

  • Strong mechanical aptitude
  • Strong written and verbal communication skills
  • Effective project management skills
  • Detail oriented
  • Ability to select, implement, and troubleshoot electrical controls-based systems.
  • Ability to communicate with contractors to outsource control needs and requirements for process equipment.
  • Ability to communicate with contractors to drive facility construction improvements for ventilation, electrical, demolition, and construction projects.
  • Work well under pressure, effectively handles conflict, strict deadlines, and multiple tasks/priorities.
  • Excellent organization and project management skills, record keeping, communication, and documentation practices.
  • Support compliance for GMP, ISO 13485:2016, MDD/MDR, and safety.
  • Ability to drive Lean Six Sigma principals to improve quality, efficiency, and waste reduction.
  • Awareness or demonstrated use of tools such as Failure Modes & Effect Analysis (FMEA), Design of Experiments (DOE), Gage Repeatability & Reproducibility (Gage R&R)
  • Demonstrated experience with SolidWorks. Should be capable of developing 2D drawings, manipulating 3D assemblies and modeling complex figures and gauges.
  • Demonstrated experience with MS Office applications.
  • Understanding of Allen Bradley PLC's including ladder logic programing is a plus.
  • Understanding of robotics selection, and programming is a plus.

ABOUT WILLOWWOOD GLOBAL LLC

The Ohio Willow Wood Company was founded in 1907 by William E. Arbogast, a bilateral amputee, on his family farm. What started as one man carving and curing willow wood for prosthetic use has evolved into an international company. WillowWood Global LLC provides prosthetic and orthotic products to clinicians and amputees around the world. We are dedicated to our mission of designing and manufacturing prosthetic products that are comfortable and functional. Every product we design aims to enable individuals with limb loss to remain active and ready to live life to the fullest.

Our vision is to "level the playing field" between physically unchallenged people and all people who find themselves challenged due to limb loss or limb dysfunction. And, we know that our employees' efforts are vital to achieving our goals. This is why we offer competitive benefits and personal development opportunities. Plus, we have a strong sense of family amongst our staff. We have also been recognized as one of the top 10 medium-sized companies to work for in Central Ohio by Columbus Business First newspaper.

ARE YOU READY TO JOIN OUR TEAM?

If you feel that you would be right for this position, please fill out our application so that we can review your information. We look forward to meeting you!

We are an Equal Opportunity Employer: disability/veteran

WillowWood
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

  • Sign Up For Job Alerts!

  • Share This Page
  • Facebook Twitter LinkedIn Email
.
Twitter Linkedin YouTube Facebook Insta Contact Us FAQ Customer Login Find Your Liner Part Logo Products Services Education Resources About WillowWood News Events Amputee Resources Home About WillowWood - lower navigation