Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
The Senior R&D Mechanical Engineer will lead projects for the Product Support group responsible for AET released products and components associated with sterile and non-sterile medical devices for minimally invasive and open surgical procedures.
* This position does not offer visa transfer or sponsorship now or in the future*

EDUCATION:

• Bachelor of Science or Master of Science in Mechanical Engineering, Design, or Science required.

EXPERIENCE:

• BS: 4 years related experience in design and testing required. Medical device experience preferred.
• MS: 2 years related experience preferred.
• Capable of performing tolerance stack analysis on high precision parts and complex assemblies, with proven understanding of medical materials and design for manufacturing (DFM).
• Proficiency in 3-D modeling software (Solidworks) and knowledge of and application of drafting practices, GD&T, ASME/ANSI drawing standards.
• Understanding the impact of regulatory requirements (eg. GMP’s, ISO 13485, ISO 14971, and MDD) on Smith & Nephew’s products.
• Working knowledge of methods typically used to evaluate materials and devices. including static and dynamic mechanical testing, corrosion, hardness, FTIR, thermal analysis methods (e.g .. DSC, DMA, TMA)
• Project management
• Effective working independently as well as in cross-functional teams with strong organizational skills, problem solving and attention to detail. Strong team player and contributor and ability to work with people at all levels of organization.
• Excellent communication skills both written and verbal.
• Flexible and adaptable at managing multiple priorities.
• Ability to make sound decisions with attention to details.
• Ability to plan and schedule multiple projects and tasks.
• MS Office, MS Excel, and Statistical software proficiency
• Physical Demands: Weight Lifting: Light (0Kg - 5Kg), Position: Standing & sitting, and Repetitive Motion : Mostly computer use.
• Travel Requirements: <10%

• Update and/or consult on R&D and Quality documentation (e.g., Design History Files, Design Control documents, Verification/Validation documentation, Risk Management files) in line with the General Safety and performance requirements specified within the MDR legislation.
• Provide team leadership or team support for Product Support projects. Seek and provide technical support for those projects. Meet design control requirements through creation of CAD models, assemblies, drawings, detailed specifications, design verification and validation plans, protocols and reports in accordance with FDA and ISO guidelines. Meet strategic deadlines, cost targets, and quality expectations for assigned projects.
• Support production facilities as needed for technical challenges beyond their expertise.
• Investigate on-market issues found in products to determine root cause, design, prototype and test potential solutions.
• Ensure compliance with the quality system and all relevant internal procedures and policies.