Reference: Posted: Location: Irvine, CACompany: Planet Pharma GroupContact: ApplicationsEmail: Responsibilities:
· Design and redesign medium to high complexity Neurovascular medical devices and subsystems.
· Supports programs led by Sustaining and NPD functions
· Test and optimize the design by designing and conducting relevant experiments and evaluations including numerical verification.
· Prepare full documentation in accordance with relevant internal SOPs and Design Control.
· Participate in pre-clinical in vivo labs, observing cases in hospitals and through planned and unplanned customer interactions.
· Create and evaluate prototypes to generate concept and model approvals.
· Write engineering reports and create presentations as required to document and communicate results.
· Prepare reports, presentations and spreadsheets of an analytical and interpretative nature.
· Institute design changes based on internal and external customer feedback.
· Collaborate with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements.
· Maintain accountability to the completion of specific programs and projects in accordance to agreed project deliverables.
· Contribute inventions, new designs and techniques regarded as advances in the medical and technical/scientific community.
· Use advanced techniques to anticipate, identify and develop solutions or alternatives to a variety of common and uncommon problems having a range of complexity.
· Provide leadership, training and mentorship to less experienced team members.
· Demonstrated ability to manage and prioritize multiple tasks/projects with a strong problem solving ability.
· Adhere to safety policy procedures.Qualifications:
· Bachelor’s degree in polymer science, Engineering, scientific, or technical discipline
· 10+ years of engineering experience
· 6+ years of medical device experience
· Thorough understanding of Neurovascular medical device industry and competitor products. Working knowledge of other related disciplines.
· Thorough understanding of clinical and regulatory pathways, IP and internal processes.
· Experience with design remediation and CAPA management
· Demonstrated ability to take initiative in keeping current with technology developments in specialized area.
· In depth knowledge and wide application of technical principles, theories, and concepts in related field of expertise to develop innovative approaches to work
· In-depth clinical knowledge for uses of product.
· In-depth knowledge of Neurovascular anatomy relative to surgical procedures for specific products.
· Ability to effectively communicate and work cooperatively with others as a lead member of a team.
· Demonstrated experience sharing information, status, needs, and issues with others in order to inform, gain input, and support decision-making.
· Expertise in catheter development and related processes.
· Equipment and tooling design.Target pay $50-70/hr based on experience level
· Design and redesign medium to high complexity Neurovascular medical devices and subsystems.
· Supports programs led by Sustaining and NPD functions
· Test and optimize the design by designing and conducting relevant experiments and evaluations including numerical verification.
· Prepare full documentation in accordance with relevant internal SOPs and Design Control.
· Participate in pre-clinical in vivo labs, observing cases in hospitals and through planned and unplanned customer interactions.
· Create and evaluate prototypes to generate concept and model approvals.
· Write engineering reports and create presentations as required to document and communicate results.
· Prepare reports, presentations and spreadsheets of an analytical and interpretative nature.
· Institute design changes based on internal and external customer feedback.
· Collaborate with peers to manage the development of appropriate testing to verify product meets internal and external customer requirements.
· Maintain accountability to the completion of specific programs and projects in accordance to agreed project deliverables.
· Contribute inventions, new designs and techniques regarded as advances in the medical and technical/scientific community.
· Use advanced techniques to anticipate, identify and develop solutions or alternatives to a variety of common and uncommon problems having a range of complexity.
· Provide leadership, training and mentorship to less experienced team members.
· Demonstrated ability to manage and prioritize multiple tasks/projects with a strong problem solving ability.
· Adhere to safety policy procedures.Qualifications:
· Bachelor’s degree in polymer science, Engineering, scientific, or technical discipline
· 10+ years of engineering experience
· 6+ years of medical device experience
· Thorough understanding of Neurovascular medical device industry and competitor products. Working knowledge of other related disciplines.
· Thorough understanding of clinical and regulatory pathways, IP and internal processes.
· Experience with design remediation and CAPA management
· Demonstrated ability to take initiative in keeping current with technology developments in specialized area.
· In depth knowledge and wide application of technical principles, theories, and concepts in related field of expertise to develop innovative approaches to work
· In-depth clinical knowledge for uses of product.
· In-depth knowledge of Neurovascular anatomy relative to surgical procedures for specific products.
· Ability to effectively communicate and work cooperatively with others as a lead member of a team.
· Demonstrated experience sharing information, status, needs, and issues with others in order to inform, gain input, and support decision-making.
· Expertise in catheter development and related processes.
· Equipment and tooling design.Target pay $50-70/hr based on experience level
MDR – Prin R-D Engineer – Exempt in irvine at Unknown Company
This position is listed as full time and onsite.