Staff Engineer, Mechanical Design R&D

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

Key Areas of Responsibility:

As part of the Patient Specific design 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 orthopedic 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 for a wide variety of implant types in order to manufacture and inspect, adhere to procedures set out by Quality and Regulatory Affairs. As proficiency levels increase, the level of responsibility will also increase which will lead to approving and signing off drawings for final release. In some circumstances you may be required to work or travel outside of normal office hours, as well as attend surgical/clinical cases.

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;
• 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/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 Quality and Regulatory Affairs counterparts;
• 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.

Education / Work Experience:

• Minimum of Bachelor’s degree in Mechanical or Biomedical Engineering . Advanced degree in a technical discipline preferred.
• 8+ years experience in medical device industry or equivalent, atleast 5 years in the similar role will be preferred
• Can use CAD to a high level to design 3D parametric models and assemblies using NX (or other mainstream software) taking into consideration manufacturing and inspection routes.
• Draft, tolerance and apply GD&T correctly and precisely to BS 8888 and related standards.
• Good understanding and qualification in mechanical engineering or similar.
• Can support various departments, including manufacturing and inspection, and maintain strict document control.
• Can implement drawing/document changes and distribute appropriately.
• Can manage and schedule multiple projects both short and long term and keep to strict deadlines in a methodical manor.
• Self-motivation and focus to work individually or in small team environments.
• An eye for creative/innovative design and attention to detail.
• Understanding of biomedical and biomechanical engineering, biotribology, or biomaterials.
• Good understanding of Siemens NX and Materialise Mimics

Knowledge / Competencies:

• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
• Curious learners. Engineers who seek out cutting-edge research and information to expand and enhance their ability to develop software.
• Goal-oriented developers. Keeping the customer and system requirements squarely in focus, people who deliver safe and robust solutions.
• User-focused creators. Engineers who design with the user in mind, developing software that helps change patients’ lives.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
• Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

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