TOP 3 SKILL SETS: Injectable device, Complaint handling, Design control
DAY TO DAY RESPONSIBILIES / FIRST 30 DAYS: complaint handling of auto injector
EMPOYLEE VALUE PROPOSITION: work for Client potential
FTE POSSIBLE EXTENSION: yes depending on his/her performance
RED FLAGS: Software experience (Not looking for candidates with Software experience)
INTERVIEW PROCESS: phone screen, 2-3 hrs interview in person with 4 people
Responsibilities:
• Support the development and sustaining of drug delivery devices
• Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems
• The qualified candidate will support technical teams to ensure successful development and sustaining of these mechanical medical devices
• The Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, clinical manufacturing, and post launch complaint handling activities of these devices
• The role of the Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support the robust of the device development and manufacturing
• Create and execute to technical protocols and prepare technical reports to support development and commercialization of the combination products.
• Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
• Create and assess product requirements to determine technical coverage and proper integration different subsystems
• Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
• Work with quality engineers and complaint managers to take care of device complaint handling and assessment including root cause analysis with tight timeline requirement
Skills:
• BS in Engineering and previous experience in a medical device industry
• 5 years current experience with engineering processes and procedures
• Supported projects from development through the 510k and PMA approval process
• Strong background in engineering and commercialization of mechanical medical devices
• Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA
• Product design/development (design control) from concept to post product launch for Europe/US
• Experience in drug/device combination product design and development
• Familiar with the following standards: o Quality System Regulation 21CFR820 o Risk Management ISO 14971 o Needle based injection system ISO -11608, FDA guidance on pen, injectors o EU Medical Device requirements Council Directive 93/42/EEC - Small scale device assembly experience
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Strong problem solving, risk assessment, and risk management
skills - Must be capable of working on multiple projects in a deadline driven environment
VERY IMPORTANT NOTE: Qualified candidates with a strong Mechanical or System Engineering background, need apply and will be considered!
DAY TO DAY RESPONSIBILIES / FIRST 30 DAYS: complaint handling of auto injector
EMPOYLEE VALUE PROPOSITION: work for Client potential
FTE POSSIBLE EXTENSION: yes depending on his/her performance
RED FLAGS: Software experience (Not looking for candidates with Software experience)
INTERVIEW PROCESS: phone screen, 2-3 hrs interview in person with 4 people
Responsibilities:
• Support the development and sustaining of drug delivery devices
• Scope includes a wide range of devices, such as; needle protection systems, fluid transfer devices, pen injectors, automatic pen injectors, and micro-infuser delivery pump systems
• The qualified candidate will support technical teams to ensure successful development and sustaining of these mechanical medical devices
• The Engineer will work closely with team members to develop detailed engineering specifications, device design & development, support verification, validation, clinical manufacturing, and post launch complaint handling activities of these devices
• The role of the Engineer is to work within a cross-functional organization to utilize technologies and methodologies that support the robust of the device development and manufacturing
• Create and execute to technical protocols and prepare technical reports to support development and commercialization of the combination products.
• Work cross-functionally with individuals and project teams in Marketing, Operations, and Development
• Create and assess product requirements to determine technical coverage and proper integration different subsystems
• Develop, execute, and review architecture documents, design documents, specifications, development plans, characterization plan, verification and validation plans and other related product development documents for assigned projects.
• Work with quality engineers and complaint managers to take care of device complaint handling and assessment including root cause analysis with tight timeline requirement
Skills:
• BS in Engineering and previous experience in a medical device industry
• 5 years current experience with engineering processes and procedures
• Supported projects from development through the 510k and PMA approval process
• Strong background in engineering and commercialization of mechanical medical devices
• Experience with material & test specs generation, protocol & report writing, process & test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA
• Product design/development (design control) from concept to post product launch for Europe/US
• Experience in drug/device combination product design and development
• Familiar with the following standards: o Quality System Regulation 21CFR820 o Risk Management ISO 14971 o Needle based injection system ISO -11608, FDA guidance on pen, injectors o EU Medical Device requirements Council Directive 93/42/EEC - Small scale device assembly experience
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Strong problem solving, risk assessment, and risk management
skills - Must be capable of working on multiple projects in a deadline driven environment
VERY IMPORTANT NOTE: Qualified candidates with a strong Mechanical or System Engineering background, need apply and will be considered!