|
Our client based in Elstree is a highly specialised organisation, focussing on orthopaedic oncology, and complex primary and revision cases in the upper limb, lower limb and pelvis. They are currently looking for a Senior Implant Design Engineer as part of the Design Services team.
You will be required to liaise with customers including, but not limited to, surgeons, theatre staff, clinical staff, distributors, and the sales force, to provide appropriate design solutions for specialist patient-specific orthopaedic devices inclusive of associated instrumentation and supporting documentation in a timely manner either independently or as part of a team and to provide technical support to other departments.
You will be required to manage your case load under tight time constraints, provide suitable drawings or CAD models in order to manufacture and inspect, approve designs for the release to manufacture, approve finished devices for final release, adhere to procedures set out by Quality and Regulatory Affairs, and mentor and cross-train other team members. In some circumstances you may be required to work or travel outside of normal office hours.
JOB DESCRIPTION
•) 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;
•) 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) as required;
•) Ensure all drawings are checked for dimensional and tolerance accuracy and where standard drawings are referenced, they include the drawing issues;
•) Approve design validity against surgeon requirements;
•) Preparation of surgical planning guides/instructions inclusive of appropriate
•) 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;
•) As part of final dispatch, ensure implants, instruments, and associated paperwork have been accounted for, are correct and complete to the requirements, approved and signed;
•) Approve implants and instruments for release at key stages including final design, release for manufacturing, and final dispatch
REQUIREMENTS
•) A thorough knowledge and understanding of designing for orthopaedics gained from a minimum of 4 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 and expectations of ISO 13485
•) A working knowledge to perform risk assessments to ISO 14971
•) To be able to communicate at different levels from junior engineers and students, to senior business managers, surgeons, and clinical staff, both written and verbal
•) Ensure all patient-specific designs are covered by an appropriate Technical File/Design Dossier/Device Master File, and where not, conduct an appropriate risk assessment and document all activities and justifications/validations to satisfy and regulatory requirements under the guidance of the RA/QA Director;
•) Provide mentoring, supervision, and training for junior designers/engineers;
•) Attend surgical and clinical cases, both domestic and abroad as required;
•) Take a lead role in the assessment and continuous improvement of appropriate business processes to support the effective continued development of the Design Services function.
Salary is up to 42000 GBP per annum.
If you would like to be considered for this role, send an updated CV to Belinda@recruitment-boutique.com
|
|
