Continuous Improvement Specialist - Irvine, United States - Orthofix Holdings Inc.

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    Continuous Improvement Specialist page is loaded Continuous Improvement Specialist Apply locations Irvine time type Full time posted on Posted Yesterday job requisition id OFX24063 Why Orthofix?We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system.

    Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginningCome join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients.

    At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by:

    Exceed Expectations, Work Together, Be Respectful, Get Lean and Have FunHow you'll make a difference?The Continuous Improvement Specialist is responsible for reviewing manufacturing processes to identify Continuous Improvement (CI) opportunities that will result in increased efficiency, cost savings, customer satisfaction through measurable Key Performance Indicators (KPIs).

    This position uses Six-sigma tools, DMAIC method, Value Stream Mapping, standard work, visual management systems, and 5S initiatives, etc.

    This role will often be the primary hands to support the team in implementation of lean process improvements to meet business objectives of our biologics manufacturing organization.

    What will your duties and responsibilities be?The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.

    Acts as a change agent in the organization by motivating change and implementing CI processes, while applying and improving existing methodologies.

    Utilizes Lean Manufacturing tools to identify and develop solutions that drive operational improvement, while working alongside cross-functional team members.

    Collaborates with key stakeholders (i.e., Manufacturing Engineering, Quality Engineering, Inventory Control, Operations, EH&S, and Maintenance) and expedites resolutions by closely tracking actions and ensuring project due dates are met.

    Designs simple manufacturing tools to assist in ergonomic and efficiency improvements.

    Participates and supports in Kaizen events; analyze and plan workflow, assist in designing new line layouts, equipment placement and space requirements to improve manufacturing efficiency and product flow.

    Executes time studies and perform line balancing activities utilizing lean principals to reduce waste.
    Identifies delays in production and sources of waste; use technology and engineering principles to refine the system.

    Supports sustainment of existing 5S program and incorporate into Daily Management SystemCollects data, creates standard work, and train manufacturing personnel to new standardsUpdates documents through change control process.

    Assists in training manufacturing team members and junior engineers to properly incorporate new technology and methods into current production standards.

    Audits all established Lean Manufacturing processes to ensure sustainability.
    Works on engineering planning, financial justifications, scale-up processes, implementations, and process validation.

    Coordinates equipment maintenance and repair services and ensures that manufacturers procedures are followed in order to keep production equipment operational.

    Engages stakeholders to understand how data driven decisions are made and provides data in a way that is easy for stakeholders to consume.

    Supports CI initiatives across multiple shifts, including 2nd shift at least twice a month.

    What skills and experience will you need?The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.


    Education/Certifications :


    Associates Degree in Engineering or Technology, or equivalent certificationExperience, Skills, Knowledge and/or Abilities :3+ years of relevant engineering, manufacturing, or continuous improvement experienceDemonstrated experience implementing and training others to use 5S, Standard Work, kaizen, kanban, and line balancingDemonstrated ability to work under pressureDemonstrated problem-solving skillsDemonstrated experience using reporting/data to support recommendationsDemonstrated ability to collaborate effectively with colleagues at various levelsDemonstrated ability to manage priorities, time, and workloadGood computer skills, including usage ofMS Office Suite (i.e., Word, Excel, and PowerPoint)What qualifications are preferred?The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.


    Education/Certifications :


    Significant understanding of Lean Manufacturing Principles and Continuous ImprovementLean Six-Sigma Green Belt certifiedAdditional Experience, Skills, Knowledge and/or Abilities :Previous experience in biotech, pharmaceuticals, or medical device industryExperience working in a controlled environment (preferably ISO class 5, 7 & 8 or better)Experience using AutoCAD, Solid Works, or similar CAD toolsPHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONSThe physical requirements listed in this section include but are not limited to the motor/physical abilities, skills, and/or demands required of the position in order to successfully undertake the essential duties and responsibilities of this position.

    In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.

    This position may require some standing.
    This position may require some bending, stooping, kneeling, or crouching.
    This position may require some walking.
    This position may require some exposure to dust, fumes, gases, odors, or other airborne irritants.
    This position requires frequent or continuous exposure to chemicals and/or solvents.
    This position is strictly an onsite position; there is no work from home allowance.

    The anticipated salary for this position for an employee who is located in California is $75,885 to $88,523 per year , plus bonus, and benefits .DISCLAIMERThe duties listed above are intended only as representation of the essential functions of this position.

    The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position.

    The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer.

    Nothing in this document alters an employees at-will employment status.

    We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.

    This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.

    About Us Since 1980, Orthofix has evolved and grown to become one of the leading medical device companies with a spine and orthopedics focus in the world.

    Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system.

    Our products are distributed in 68 countries worldwide.
    Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy.

    Our combined companys global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and Sao Paulo, Brazil.

    Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design & Outsourcing magazine.

    Orthofix is committed to improving patients lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day.

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