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  • Senior Engineer, Mechanical, West Chester PA

    Discussion in 'USA jobs' started by KMitchell, Sep 19, 2013.

    1. KMitchell

      KMitchell New Member

      Sep 2013
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      THERAKOS® is a global leader in advancing the science of extracorporeal photopheresis (ECP). For 25 years, THERAKOS® employees have pioneered new and industry leading technologies. As we look to drive the next phase of Therakos’ growth, we are seeking to expand our team with talented leaders and professionals in all functional areas. THERAKOS® offers a range of opportunities to work and grow in an organization built around innovation and centered on patients.

      THERAKOS® is currently seeking Senior Engineer reporting to the Engineering Program Manager. The incumbent will carry out or direct the development /sustaining activities of complex consumable medical devices. The Sr. Mechanical Engineer will manage individual development projects within a team environment to support concept and engineering development efforts, as well as to facilitate design for manufacturability efforts. The incumbent will be responsible for the proper application of technologies and process that ensure compliant and efficient manufacturing transition and product sustenance and will deliver requirements, specifications, verification and validation activities to support applicable development, manufacturing, obsolescence, software and hardware changes, clinical studies, and labeling changes.


      • New Product Development / Sustaining engineering development
      • Manufacturing transition activities
      • Coordination and management of engineering projects
      • Coordination of external development/engineering partnerships

      · Implement and manage product design development and sustenance programs that support business initiatives
      · Lead, develop and implement design characterization or design verification and validation strategy for efficient, complete and robust testing through report completion and anomaly resolution or independently perform tolerance, error budget or other design analysis by extending or adapting existing methodologies.
      · Assist with conformance to Therakos design control and risk management policies to ensure product quality through technical review of work product of other team members and projects.
      · Provide technical leadership and become a recognized company expert on technical aspects of Therakos medical devices and develop working knowledge of internal and external manufacturing systems. Develop and deliver technical presentations to internal stakeholders including costs of features in terms of cost and schedule impact.
      · Technical team member of the Product Development team engaged in new product and sustaining development activities delivering quality work to ensure that Therakos delivers the highest quality product to its customers. Provide engineering expertise on technical aspects of internal and external products and systems.
      · Lead the establishment of design requirements from VOC and translate into objective and meaningful lower level engineering requirements including those of a complex or difficult nature.
      · Perform project management activities through the leadership / direction of cross functional internal resources and external development contractors for individual development programs or portions of larger programs.


      • BS in engineering with 5+ years of applicable industry experience is required. MS/MBA or advanced degree a plus.
      • Independent innovative thinker with strong background and experience in life sciences, bioengineering, medical device design / development through launch of complex consumable medical devices.
      • Experience in development of complex sophisticated medical devices and validation activities.
      • Experience in outsourced medical device manufacturing, manufacturing technologies and process development.
      • Knowledge of medical device regulations including FDA GMP, design controls, ISO13485, ISO 14971, regulatory audits and international environmental regulations. Track record of success in the development of 510K/PMA regulated products.
      • Excellent written and verbal communications skills.
      • Candidate must be able to weigh, document and articulate the strategic and tactical alternatives that deliver complete, reliable and high performing systems that meet customer and business needs.
      · Experience in sterilization of consumable devices a plus.

      This position will be located in our West Chester, PA office.

      For more information please contact:
      [email protected]


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