R&D Engineer III

Responsibilities

• Own the end-to-end execution of product engineering projects, including Sustaining Change Requests, Product Stewardship requests, and Obsolescence projects.
• Extract, collect, analyze, and summarize data files and report to stakeholders.
• Design, develop and implement products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings.
• Select appropriate materials, processes and vendors to achieve the design.
• Challenge these designs against design specifications, clinical use scenarios and international standards.
• Plan, coordinate and build test parts for engineering evaluation, pre-clinical studies and clinical studies.
• Make and present engineering decisions.
• Participate and lead cross-functional teams through design and development stages.
• Develop new or existing processes by understanding key process inputs and outputs, using statistical methods such as DOE as appropriate.
• Develop process equipment and tooling, including specification development, vendor selection and negotiation.
• Prepare work instructions and standard operating procedures (SOP), write technical documents and reports.
• Prepare raw material specifications and drawings.
• Prepare verification and validation protocols and reports.
• Develop or modify test methods and clinically relevant simulated use test methods in conjunction with R&D technicians.

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
• Minimum of 6 years of industrial experience, preferably in R&D or process development.
• Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation.
• Training in Six Sigma or Design for Six Sigma.
• Master’s degree in relevant engineering discipline plus 1-3 years medical device or equivalent industry experience (preferred).
• Experience in R&D or process development in medical device or other regulated FDA/QSR and ISO environment.
• Knowledge of cGMP and GLP.
• Experience creating and executing project plans.
• Experience and willingness to lead cross functional teams, across multiple time zones (Domestic and International).
• Experience in project management tools and methodologies.
• Basic tooling, design and drafting knowledge.
• Proficient in statistical software with ability to analyze data, interpret results, and write reports.

• Mechanical Engineering
• Biomedical Engineering
• Process Development
• Design Specifications
• Test Method Development
• Technical Documentation
• Material Selection
• Engineering Drawings
• Verification and Validation Protocols
• Statistical Analysis

• Communication
• Collaboration
• Leadership
• Problem-Solving
• Presentation Skills

• Six Sigma Certification