R&D NPD Engineer- Medical Devices

Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a  R&D NPD Engineer- Medical Devices for a long-term engagement at one of our Global clients in Miami, FL. 

This role is a full-time, fully benefited position.   As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from.   You’ll also be eligible for paid time off, including holiday, vacation and sick/personal time.  All KellyOCG employees receive annual performance reviews. 

 

As a Sr. R&D Product Design Engineer placed with KellyOCG you will be responsible for the following:

 

R&D Engineer III:                                                                                                                                                                                                                                                                                                                                                                                                       Responsible for ensuring personal and company compliance with all international, federal, state, local and company regulations, requirements, policies, and procedures

• Responsible for ensuring that subordinates follow all company guidelines related to health, safety and environmental practices
• Apply knowledge of engineering principles, materials, reliability to achieve product design requirements
• Interacts with doctors and/or scientific institutions to gather voice of customer Interprets customer and marketing input to define/refine technical design solutions Develops design concepts and prototypes
• Characterizes product design and processes
• Generate and submit novel, innovative product design, process or method ideas into the intellectual property database, provides support to patent attorneys for patent filing  Work with patent attorney(s) on IP searches and clearances
• Perform detailed design analysis and provide input or approval for detailed design specifications Establish appropriate statistical testing strategies and perform product testing to ensure adequate safety factors or margins
• Assist and/or develops and monitors project plan, budget, contingency plans and work estimation Provides technical support or leadership to product development team
• Provide peer feedback and may mentor junior associates as assigned
• Utilizes geometric tolerance methods and tolerance stack-up methodologies to translate performance level and system level requirements to drawings and components
• Supports the application of manufacturability principles (tooling, process, cost) to component and product designs
• Supports the development of Risk Management Documentation Supports the regulatory filing process

Responsible for the following design deliverables as applicable:

• Requirements Traceability Matrix
• Surgical Technique
• Biocompatibility Assessment
• Characterization Protocols and Reports
• Shelf Life Assessment
• Test Methods development and Validation
• Tolerance Stack-Up Analysis
• Drawings & Specifications
• Design Master Record
• Design Verification and Validation Master Plan
• Design Validation Protocols and Reports
• Accelerated Aging Protocols and Reports
• Software Validation Protocols and Reports
• Complaint handling and failure analysis training
• Design reviews

Duties and Responsibilities shown above will vary depending on position level, not all duties and responsibilities listed may be assigned

General Skills

• BS degree in Science along with 5 years industry experience. 
• EUMDR, understanding of US & foreign government regulations-ISO (International Organization for Standardization) and GMP
• Effective oral, written and presentation communications
• Technical writing; protocols, testing results, procedures, status and special reports project management skills
• Conflict analysis and resolution
• Negotiation and networking (e.g., internal and external customers)
• Able to work efficiently and effectively in an ambiguous environment
• Able to adapt to shifting priorities, resolve problems and conflicts
• Able to initiate and be self-managing
• General design engineering principles
• DOE ( Design of experiments )
• Knowledge of intellectual property fundamentals and legal processes for managing intellectual art
• Working knowledge of mechanical testing of systems, sub-systems and components
• Knowledgeable of medical terminology, procedures and instrumentation
• Working knowledge of applicable requirements related to the MDSAP jurisdictions

Technical Skills

• Mechanics of materials and failure analysis, Geometric tolerance and tolerance stack-up analysis
• Measurement system analysis including gage repeatability and re-calibrations system and methodology
• Understanding of adhesives, polymers, elastomers and sealants
• Special design analysis software (e.g., FEA, Mahlab, MiniTab) CAD SW proficiency

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. 

Applicants must be legally permitted to work in the United States immediately and without employer sponsorship (F1 OPT cannot be considered for this position). 

Why Kelly®?

As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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