Ortho Clinical Diagnostics

  • Senior Engineer and Project Manager EMEA

    Job Locations GB-Pencoed
    Posted Date 2 weeks ago(10/7/2018 12:43 PM)
    Job Country
    United Kingdom
  • The Company

    Ortho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics.  Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.


    With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.


    Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.


    Ortho’s purpose is simple: to improve and save lives with diagnostics. They do that by reimagining what’s possible. It’s what defines them. It’s the Ortho difference.


    Ortho is an independent company, sponsored by The Carlyle Group, one of the world’s largest and most successful investment firms. The company's executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.

    The Career Potential

    Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.


    Ortho is known in the industry as a leader in customer service and support.  Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do.  It’s who we are.  If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

    The Opportunity


    As the company continues to grow, we are seeking a Senior Engineer and Project Manager EMEA.


    An exciting opportunity exists to join a global team of engineers responsible for the technical management of Ortho’s suppliers.  This position will serve as a point of contact for supplier related needs for raw material components which serve the Pencoed Facility manufacturing operations as well as some finished goods.  In addition, the role will integrate with a network of colleagues across the US and EU to ensure flawless management of Ortho’s supplier managed assets proving leadership for effective troubleshooting and resolution of issues to ensure supply continuity, as well as expert delivery of capital projects.


    The Responsibilities

    • Manage projects for the introduction of new assets or process improvements of existing assets at Suppliers. This may include: supplier improvements, quality improvements, supplier certifications, validations, change control, closure integrity, design/artwork, cold chain, technology transfer, new molding tools and factory automation systems
    • Responsible for completing failure investigations for customer complaints, CAPA's and NC's.
    • Work with suppliers to validate process changes, address obsolescence issues, and provide change oversight.
    • Application of Six Sigma tools to drive supplier certification goals and quality improvements
    • Lead and execute supplier Installation, Operational and Performance Qualifications for equipment, component, material and process changes
    • Participate/lead teams to improve supplier performance and total delivered cost
    • Maintain/communicate supplier metrics and/or scorecard as needed
    • Maintain clear communication with internal and external business partners regarding progress, expectations, satisfaction, and/or quality of results


    The position will be based in our Pencoed facility and may require up to 30% domestic and international travel. 

    The Individual

    The position would ideally suit someone with a strong background in working with external manufacturers such as injection moulding or bespoke automated equipment, or someone from a successful manufacturing engineering background looking to make a transition to supply chain technical operations.

    Due to the breadth of skills required and autonomy needed, the role will be, or will be working towards being a senior position within the group’s engineering community depending on the successful applicant’s current level of experience. 


    Qualifications and Skills

    • The qualified candidate must meet a minimum requirement of a Bachelor’s degree in Engineering and minimum 10 years of experience in Mechanical, Chemical, Industrial or Package Engineering.  Candidates with a minimum of 5 years medical device experience are preferred. 
    • The successful candidate will be able to demonstrate a track record of delivering complex technical projects with 3rd parties within a highly regulated environment using Six Sigma methodologies when called for.  Possession of a Six Sigma Methodology Certification would also be an advantage.    
    • Knowledge and practical experience with process development, process controls and process validation (e.g. control plans, pFMEAs, SPC, etc.) is essential.  Experience conducting root cause/failure investigations using formal methodologies is also required.  
    • The position would ideally suit candidates who enjoy communicating with and influencing diverse stakeholders and developing cross-functional partnerships such as R&D, Strategic Sourcing, Quality, Regulatory Affairs, etc.

      Likewise, the candidate should thrive in the exposure this role will provide; confidently interfacing with diverse groups both internally and externally; either face-to-face or via remote conferencing.

    • Finally, it is essential that the candidate has strong decision making skills, is results driven and enjoys working to deadlines







    Equal Opportunity

    At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career. 


    Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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