The individual will be part of the R&D team within the Image Guided Therapy Devices (IGTD) business group is a team that is driven to providing products and solutions, working collaboratively within and across business groups. He/she will evaluate material and chemical composition of medical device components for compliance to EU REACH Directive 1907/2006, and RoHS Directives 2011/65/EU and 2015/863 identifying CMR substances. Individual will work with component suppliers, and cross-functional IGT-D engineering and regulatory teams to resolve any documentation gaps and update technical files
Performs technical review of the material and chemical composition of the product components. Will utilize engineering drawings and SDS information, REACH and RoHS Declarations, Biocompatibility and Restricted Substance test reports and BOMCheck to perform review. Identifies any carcinogenic, mutagenic or toxic substances identified during the review; and will report information up to the project team and update device history file accordingly within the PLM system
Collaborates with R&D, Procurement Engineering and/or Supplier Quality and the supplier to obtain missing documentation to support technical review of the material and chemical composition of the product components
Researches material and chemical information as needed via chemical information portals
Calculates hazardous substance levels and works with Philips Central Team to include device on Philips Sustainable Product portal
III. REQUIREMENTS:
EDUCATION:
Requires a Bachelor's degree in a Science (Chemistry, Biochemistry, Microbiology, or Biology) or Engineering (Materials, Mechanical, or Industrial) discipline with a minimum of 2 years of experience in the Pharmaceutical/Biotechnology or Medical Device industry.
SKILLS AND EXPERIENCE:
• Experience with material / chemical characterization with a strong knowledge of wet chemistry applications, chromatography, and spectroscopy is preferred
• Experience with resin / plastics which a knowledge of process chemistry is preferred
• Knowledge of 21CFR210, 211, or 820; EU MDR 2017 and ISO 13485:2016 Regulations is preferred
• Ability to work in a team environment to ensure conducive working relationships.
• Ability to work with vendors/suppliers
• Demonstrate organizational and interpersonal skills working in a cross-functional, regulated environment
• Strong verbal and written skills
• Strong analytical skills.
• Ability to organize and prioritize workflow in order to meet established time frames and schedules.
• Proficiency in Microsoft Word, Excel, Powerpoint,
• The position is located in the San Diego Philips office.
• There is 0% travel required for this position.