Here are some of the job duties:

• Participate in development projects following established FDA design control procedures; from feasibility through production implementation, and release to market phases.  
• Develop and execute validation strategies for medical device cleaning, biocompatibility, functional performance and packaging studies that challenge the status quo.  Write protocols, validation plans, procedures, analyses and reports.  Create and maintain the design history file (DHF) and any other records created as part of the development efforts.
• Work with multidisciplinary project teams to ensure projects meet established schedules. May serve as the project lead to direct activities related to product development.
• Develop and write Standard Operating Procedures (SOP’s) for processing devices in production.
• Engage outside contracting services in support of project needs, i.e. analytical laboratories, consultants, material suppliers and equipment suppliers.  Build effective relationships with these resources to meet delivery and budgetary goals.
• Effectively communicate cross-functionally within the organization with teammates in: Manufacturing, Quality, Product Management, Marketing, Sales, and Regulatory.
• Research and understand device functionality, device patents, and clinical use.

Medline offers a business casual, entrepreneurial work environment with strong growth potential, a competitive compensation package, and a complete benefits package including medical/dental/vision/life insurance; 401(k) with company match. And much more! 

Required Qualifications:

• Bachelor’s degree in an Engineering discipline
• At least 2 years engineering experience
• Technical writing, research paper writing, and/or experimental design experience
• ERP systems knowledge and experience
• Intermediate skill level in computer and systems use (Microsoft Word, PowerPoint, and Excel)

Nice to haves but not required:

• Bachelor’s degree in Mechanical, Electrical or Biomedical engineering.
• Prior experience working with electrophysiology (EP) catheters or similar cardiac medical devices
• Prior experience working with medical devices; development, reprocessing and/or manufacturing
• Prior experience working in a FDA regulated industry/field, or similar
• Exposure to the FDA 510(k) process or other regulatory submissions
• Experience measuring, conducting testing functions, interpreting and performing test procedures, operating testing equipment and creating/documenting test procedures and results.
• Prior experience in a LEAN Manufacturing/Production environment, GMP and/or New Product Development
• Prior design experience in CAD using SolidWorks
• Prior experience reading and interpreting standards and guidance documents