Product Development Engineer

Product Development Engineer

Location: Stryker Anngrove, Carrigtwohill, Cork

Contract: 23 Month Contract

Who we want:

• Collaborators - Partners who listen, share thoughts and work together to build and leverage relationships to meet project goals.

• Problem solvers - Critical thinkers who are motivated to solve challenging problems.

• Dedicated achievers - Those who aspire for excellence in a fast-paced environment and take ownership of their work.

• Customer-focused - Engineers who can partner with our customers to drive purposeful innovation, resulting in best-in-class products.

Position Summary:

The Patient Specific Solutions team provides patient-specific devices to those with complex clinical cases, such as oncology cases, where no other device exists on the market to treat their condition. These are provided under the prescription of the overseeing physician in accordance with all applicable laws and regulations for single patient use. As an engineer on the Patient Specific Solutions team, you will perform implant and instrument design work for individual cases. You will be required to liaise with customers including, but not limited to, surgeons, OR staff, clinical staff, distributors, and the sales force, to provide appropriate design solutions for patient-specific orthopaedic devices inclusive of associated instrumentation and supporting documentation. You will deliver this in a timely manner either independently or as part of a team and you will 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 for a wide variety of implant types in order to manufacture and inspect, and adhere to procedures set out by Quality and Regulatory Affairs. In some circumstances you may be required to work or travel outside of normal office hours, as well as attend surgical/clinical cases. 

What you will do:

• 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, apply geometrical tolerancing, finishing and etching details, and carry out tolerance stack calculations; 

• 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 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/OR 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; 

• Conduct, as part of a team, risk assessments and document all activities and justifications/validations to satisfy regulatory requirements under the guidance of the Quality and Regulatory Affairs counterparts; 

• Attend surgical and clinical cases, as required;

• Any other tasks that sits outside your current role from time to time to support the activities of the business.

What you need:

• Bachelor’s degree required; in a science or engineering discipline, Mechanical or Biomedical Engineering preferred.

• 0-2 years of product design experience in the medical device industry or equivalent.

• Fundamental understanding of design controls and risk management within a regulated industry, preferred.

• Fundamental understanding of a parametric CAD design package. Pro/Engineer preferred.

• Demonstrated ability to develop into self-starters, have a hands-on approach and learn to work independently.

• Ability to communicate effectively by written and oral means.

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