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Staff Engineer, R&D - Patient Specific Solutions - Elstree - Stryker Corporation

Date de publication : 5/14/2019

Résumé de l'offre

  • Type de salarié :
    CDI / CNE
  • Lieu :
    Elstree
  • Type d’offre :
  • Expérience :
    Not Specified
  • Date de publication :
    5/14/2019
  • Job ID:
    R411063

Description de l'offre

Key tasks

The job holder will be responsible for carrying out the following:

  • Provide design solutions for a broad range of patient specific implants inclusive of instruments and trials where necessary;
  • Ensure all solutions meet critical design prerequisites including patient and customer safety, mechanical, and biological suitability;
  • Read and work from various clinical imaging including x-rays, CT, and MRI scans;
  • Provide adequate information via technical drawings and 3D models to manufacturing and inspection (including subcontractor activities such as coating requirements) and prepare job cards and bill of materials (BOMs) with reference drawings as required;
  • Where required, dimension all drawings correctly in accordance with the latest version of BS 8888, apply geometrical tolerancing, finishing and etching details, and carry out tolerance stack calculations;
  • Approve design validity against surgeon requirements;
  • Perform engineering calculations, making reasonable assumptions, to support design validity;
  • Preparation of surgical planning guides/instructions inclusive of appropriate surgical instruments and defining operating instructions for patient-specific implants;
  • Liaise with Design Services’ coordinators, Manufacturing Team Leaders and technicians, Product Engineers, Inspectors, Customer Services, QA/RA personnel, and subcontractors with respect to the manufacture and progress of each case; 
  • Liaise with consultant surgeons, surgical/theatre staff, distributors, and the Sales team with respect to implant design, instrumentation and technical support;
  • Ensure standard templates used for design are current and updated in a timely fashion;
  • Ensure all patient-specific designs are covered by an appropriate Technical File/Design Dossier/Device History File;
  • Conduct, as part of a team, risk assessments and document all activities and justifications/validations to satisfy regulatory requirements under the guidance of the RA/QA Director;
  • Attend surgical and clinical cases, both domestic and abroad as required.
  • Any other tasks that sits outside your current role from time to time to support the activities of the business.

    Support tasks

  • Addressing Non-conformities.
  • Provide product development support for METS, ITAP and other commercial projects and where necessary, provide project definition, schedule preparation, cost preparation, and project implementation;
  • Provide product training to customers and sales forces as required;
  • Conduct feasibility studies as part of a team with customers for new commercial product opportunities;
  • Conduct all activities in full compliance with MDD and FDA Design Controls requirements;
  • Assist in continuous improvement projects in the design services function and throughout the product development team;
  • Attend conferences, specialist meetings, and trade shows when required;
  • Attend appropriate training programs for both self-improvement/development and health and safety;
  • Interact with and support the product management team as required in the generation of effective and appropriate product support materials;
  • Any other activity related to Custom Design appointed by the Head of Custom Design.

    Performance measures

  • On time, on budget
  • Product meets regulatory requirements
  • Internal and external customer satisfaction

    Qualifications, skills and desirable experience

  • Knowledge and understanding of designing for orthopaedics gained from a minimum of 2 years working within the industry;
  • A high level of engineering proficiency;
  • Good 3D CAD modelling and drafting skills including parametric modelling, production of engineering tolerances, and working knowledge of GD&T;
  • Knowledge of engineering and implant materials;
  • An understanding of human anatomy;
  • Ability to work from an array of clinical imaging including x-rays and CT scan data;
  • A working knowledge of ISO 13485
  • A working knowledge to perform risk assessments to ISO 14971
  • To be able to communicate at different levels from fellow engineers and students, to senior business managers, surgeons, and clinical staff, both written and verbal.

Special features

Stanmore Implants Worldwide Limited operates under strict Quality procedures and where these relate to your role you should aim to achieve the required levels of conformity as necessary.  This will ensure that you are fully aware that any non-compliance or improper performance of your role may occur in a defective device.  You also should need to ensure that you remain up to date with the contents of the Quality manual and how this affects your duties.

Work From Home: No

Travel Percentage: Up to 25%

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