Patient Specific Solutions, Associate Engineer
POSITION SUMMARY:
The Patient Specific Solutions, Associate Engineer is responsible for reviewing and processing patient data and creating pre-operative alignment reports and patient specific instrumentation for products designed at Stryker. Candidate must possess intermediate CAD knowledge and exhibit aptitude, strong organizational skills, and familiarity with computer systems.
Responsible for quality, timely design and development of project segments which may have an impact on the company's short, mid, and long-term sales goals.
You will perform instrument design work for individual cases.
You will be required to manage your workload under defined timelines, provide suitable drawings or CAD models for a wide variety of implant types to manufacture and inspect, and adhere to procedures set out by Quality and Regulatory Affairs. Additionally, the PSS Engineer is responsible for reviewing data of coworkers for accuracy and must maintain professional working relationships with technical consultants, surgeons, and all individuals within the organization, who are involved with product research, design, development, and commercialization.
What you will do:
Under supervision, design, develop, modify, and verify mechanical components for patient specific devices.
Support problem solving, root cause analysis, identify potential solutions, and evaluate them against requirements.
Ensure all solutions meet critical design prerequisites including patient and customer safety.
Read and work from various clinical imaging including x-rays and CT scans.
Provide adequate information via technical drawings and 3D models to manufacturing and inspection.
Preparation of surgical planning guides/instructions inclusive of appropriate surgical instruments and defining operating instructions for patient-specific implants
Review coworkers preop reports and patient specific instrumentation design and specifications.
Business Responsibilities:
Interpret customer needs and understands design inputs.
Understand the product’s intended use and clinical procedures.
Establish and maintain strong working relationships with all functional areas within the company to insure timely and smooth product development, design, manufacturing, and commercialization.
Any other tasks that sit outside your current role from time to time to support the activities of the business.
Med Device Compliance:
Understand fundamental industry standards, design requirements and test strategies which align with regulatory requirements.
Learn R&D procedures like design controls and risk management, per the Quality Management System..
What you will need:
With supervision, work with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.
Fundamental knowledge and understanding of mechanical engineering practices and tools, design principles within a regulated environment.
Basic knowledge of analysis tools and statistical methods.
Ability to read and interpret complex drawings.
Intermediate experience with SolidWorkds or other CAD softwares
Some knowledge of orthopedic / mechanical products, ASTM/ISO Standards, radiology.
English Level (Preferred): B2 (CEFR standard)
