Medical Product Manufacturing
Since 1963, Cook Group companies have been among the leaders in developing healthcare devices that have improved lives around the world. COOK remains at the forefront of medical research and worldwide sales of products for endovascular therapy, critical care medicine, general surgery, diagnostic and interventional procedures, bioengineered tissue replacement and regeneration, gastroenterology and endoscopy procedures, urology, and obstetrics and gynecology. COOK is a global company with a global focus - and a global future.
The Development Engineer leads the design and development for new products and innovations, focused on addressing business and market needs for the Strategic Business Unit.
Essential Job Functions/Duties (may include other duties as assigned)
• Define concepts
• Build prototypes
• Create clinically simulated bench tests
• Verify and validate designs
• Transfer designs into production
• Interface with Marketing, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors and physicians
• Manage multiple project time lines, resources and responsibilities to achieve team, departmental and Business Unit goals
• Follow Design Control procedures and comply with requirements of 21CFR Quality System Regulations, ISO 13485 and ISO 14971
• Provide direction to engineering technicians or other engineering employees
• Lead cross functional teams
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral and written communications throughout various levels of the global organization
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations
Minimum Work Experience/Educational Requirements
• BS in Engineering or experience of such kind and amount as to provide a comparable background
• Comprehensive knowledge of mechanical engineering principles, mechanical properties testing, mechanical design and theories
• Minimum of 3 years of industrial experience in design and development of medical devices or a related field
• Previous project management experience preferred
• Proficient in part design working with modeling software (Solidworks or Pro E preferred)
• Basic knowledge of statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and problem solving
• Strong hands on skills and mechanical abilities
Physical Requirements/Work Environment
• Works under general office environmental conditions.
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Personal protective equipment including safety glasses, lab coat and gloves required in many areas associated with this position.
401(k) retirement savings plan with company match
Medical, dental, and vision
Paid time off
Flexible spending account
Cook is an Equal Opportunity Employer
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...