Staff Manufacturing Engineer

Staff Manufacturing Engineer

As a Staff Manufacturing Engineer, you will take ownership of managing and improving manufacturing processes to support operational strategic goals. You will continuously drive to keep assigned manufacturing processes as current and efficient as possible, especially regarding process equipment, systems, and workflow. Additionally, you will collaborate with suppliers on orthopedic devices to ensure a quality product is delivered, while working collaboratively with design, quality, regulatory, supply chain, etc. This full-time onsite position is available to start immediately and is a great opportunity in the exciting medical device industry. Location: Onsite - Draper, UT Schedule: Monday-Friday

Your responsibilities:

• Responsible for manufacturing processes for orthopedic devices, including procedures, instructions, process validation, supplier qualifications, and monitoring to ensure product consistency and compliance with QMS and standards
• Modeling skills with experience in solid modeling packages such as CREO, Windchill, SolidWorks, etc.
• Validation experience i.e., IQ, OQ, PQ requirements
• Capital equipment purchases utilizing URS, FAT, SAT
• Identify and implement process improvements to enhance efficiency, reduce costs, and minimize waste
• Collaborate with R&D for product design, ensuring new devices are designed for manufacturing
• Ensure manufacturing processes meet applicable FDA, ISO, and other industry standards
• Partner with Quality to develop and maintain manufacturing quality control processes
• Coordinate with suppliers for product/material quality and ensure timely deliveries
• Provide guidance and mentorship to junior manufacturing engineers and production staff, fostering a culture of continuous improvement
• Lead extensive CapEx projects up to and including facility upgrades and relocation
• Address non-conformances and CAPAs as needed
• Perform other job-related duties as assigned

Requirements:

• Bachelor of Science degree in engineering or related field
• 10+ years experience in Manufacturing Engineering or similar
• Strong interpersonal skills required in the areas of verbal and written communications, customer focus and professionalism, self-starter
• Strong listening, questioning, problem-solving and assessment skills
• Proficient in the use of MS Excel, including pivot tables, vlookups, graphs and macro's is required (Preferred)
• CAD CAM experience with Creo (Preferred)
• Knowledge of statistical analysis with MiniTab or other statistical software (Preferred)
• Training in Lean Six Sigma, Project Management, AutoCAD, GD&T (Preferred)