Careers

Job Responsibilities and Duties include:

• Identify, prioritize and drive manufacturing and quality improvement projects
• Integrate technical advancements into manufacturing processes and equipment of existing and new products
• Improve and maintain custom designed machines

Qualifications

• 3 – 5 years experience in the medical device industry preferred
• A bachelor’s degree in mechanical engineering is required. Experience with laser technology, iodination, and radioactive materials handling
• CAD experience with Solid Works
• Knowledge and experience with Six Sigma and Lean Manufacturing tools and techniques.  Certification in these disciplines is preferred
• Strong computer skills

Personal Attributes

• Exceptional troubleshooting and problem solving skills
• Strong communication skills and ability to work in a dynamic team environment
• Ability to manager multiple priorities
• Proactive and self-directed

To Apply - Send resume and cover letter to manufacturingjobs@coreoncology.com.

Quality Engineer Associate

Essential Duties

• Create and analyze designed experiments and tests to gain further knowledge of the variables affecting component, product, and process quality
• Assist in the development of new products and design and validate test and inspection methods
• Creates design documentation for new medical devices such as design input and output, validations, and product verification
• Research various aspects pertaining to radioactivity and the human body and material biocompatibilty
• Develop product and process validations to assure that products meet predefined criteria
• Perform internal quality audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions
• Assist in assuring that current Product Development projects and design change projects meet the intent of design controls
• Work with Project, Design, and Manufacturing Engineers to execute quality activities for new products and processes
• Use and provide guidance on the use of statistical applications for various analyses including the mean time to failure, correlation studies and statistical process control
• Assist with the development and execution of product regulatory submissions and filings
• Assist with the execution of facility regulatory submissions and filings
• Recommend and implement quality system improvements to enhance regulatory compliance, improve quality, and reduce costs
• Assist in the implementaation of engineering changes to product and component design; evaluate the safety of changes to product and component design
• Create and maintain company quality documentation, such as quality manuals, quality procedures, etc.
• Assist in the performance and update of risk assessments for new and existing products and processes
• Develop training to build quality awareness
• Act as the project team leader for assigned projects
• Other duties as assigned

Requirements

Education:

Bachelor’s degree in Engineering, Engineering Technologies or Biomedical Sciences and / or minimum of 4 years related experience in the medical device industry with exposure to FDA-QSR requirements.

Experience/Qualifications/Requirements:

• Minimum of 2 years experience with relevant quality experience in the medical device industry and exposure to FDA-QSR requirements
• Ability to read, understand, and translate government and industry standards, product specifications, and blueprints; examples are FDA and ASTM
• Must be familiar with geometric design and tolerance
• Experience with statistical techniques
• Must have excellent communication skills, both orally and written,and must be to communicate with all levels within the company
• Work independently, and proactively
• Must take prompt action to accomplish objectives; must take action to achieve goals beyond what is required; must be proactive.
• Must be able to learn and understand basic principles of radioactivity and radiation safety
• Must have strong organizational, problem solving, and planning skills
• Must have initiative and sound decision making ability
• Must be proficient with the use of a personal computer and have a working knowledge of Windows XP and Office 2007

Preferred Experience

• Prior work experience with quality systems while in a manufacturing environment, and exposure to NRC, ISO 13485, CMDR, and MDD
• A current certification of Certified Quality Engineer (CQE)
• Experience performing quality audits
• Experience with continuous improvement, six-sigma, or similar programs and advanced techniques

To Apply - Send resume and cover letter to manufacturingjobs@coreoncology.com.