FEATURED JOB OPPORTUNITIES
Senior Research and Development Engineer
Design, develop and update cardiac implants and delivery catheters for treatment of cardiac valve insufficiency. Position includes primary management of a development project of broad scope with only high level guidance from management. As Project Leader, the engineer will also serve as the primary technical contributor and may be responsible for supervision of technical personnel. Project ownership extends from conceptualization through manufacturing ramp up.
- • Develop catheters, handles, implants and other medical devices within the EN 13485 compliant design control process
- • Manage and maintain primary leadership of assigned project through the design control process from concept through manufacturing transfer to product commercialization
- • Create and manage timelines for projects from concept through commercialization
- • Proactively communicate program progress, risks and recommendations to management as appropriate
- • Develop and document thorough and accurate specifications for devices, components and materials
- • Develop test methods, create written procedures and as needed perform product testing
- • Develop robust manufacturing processes and create written procedures
- • Conceive, design, document and sometimes fabricate fixturing for test and assembly
- • Develop, build and iterate product prototypes
- • Provide routine verbal updates to management and written reports of work
- • Design, execute, analyze and document engineering experiments to guide product and process development
- • Select and interface with vendors in all phases of product development including prototyping, development and initial production
- • Operate within Mitralign procedures and industry standards for product development and manufacture
- • Maintain laboratory notebooks to document work activities
- • Participate in clinical activities including observing medical procedures and interfacing with clinicians
- • Participate in animal studies related to development work
- • Participate in patent related activities related to development work
- • Participate in production build and QC inspections activities as needed
- • In addition to the essential functions listed above, other responsibilities and key result areas as assigned
• Engineering technician or intern.
• BS degree in engineering (Biomedical, plastics, mechanical or similar)
- • Minimum of 7 years of hands-on experience in medical device design and development
- • Experience with primary project ownership while contributing to multiple parallel projects
- • Experience interfacing with clinicians within the product development process
- • Experience with primary and secondary processes commonly used in catheter assembly, including injection molding, extrusion, melt and adhesive bonding and machining
- • Cardiovascular device experience preferred
- • Experience with catheter development preferred
- • CAD experience a must (preferably SolidWorks)
- • Good mechanical aptitude
- • Practical understanding of materials properties, stress/strain, kinematics/dynamics and various fabrication processes and technologies
- • Experience with polymeric materials and metals and their properties
- • Ability and personality to manage projects in a fast-paced small company environment
- • Understanding of regulatory requirements associated with medical technologies
- • Must have working knowledge of ISO 13485 and FDA Quality System Regulations
- • Team player possessing a high level of ethics and professional integrity
- • Ability to produce prototypes and test units in an engineering lab environment
- • Excellent verbal & written communication skills applied within the company and with vendors and consultants
- • Must be able to work independently and be self-motivated
Physical Demands and Conditions Requirements
- General office and engineering lab environment.
- General office equipment. Hand tools and machine tools
Senior Regulatory Affairs Specialist
The Regulatory Affairs Specialist will provide worldwide regulatory affairs support for Class III medical devices. The Regulatory Affairs Specialist is responsible for activities that lead to, and maintain regulatory approval for these medical devices. Additionally, the Regulatory Affairs Specialist is responsible for assessment of device changes for regulatory implications and for performing regulatory activities in support of these device changes.
- • Prepare global regulatory submissions such as EU Design Dossiers, IDE, PMA submissions and supplements.
- • In collaboration with Director, develop global regulatory strategies to seek approvals for new and modified devices worldwide.
- • Obtain and maintain registration of assigned products in rest of world markets
- • Provide regulatory support to currently marketed products, as necessary. Assesses product and manufacturing changes for compliance with applicable regulations and prepare submissions and reports as required by classification and geography.
- • Review device labeling, advertising, sales support and training materials for compliance with submissions and applicable regulations.
- • Provide regulatory support for product design, manufacturing, packaging, sterilization, and labeling changes.
- • Provide regulatory affairs input for product development and manufacturing, including review of specifications, protocols and reports, engineering change notices, nonconforming materials, product complaints, and product failure analysis.
- • Provide regulatory input to the company for compliance with ISO and FDA Quality System Regulation requirements.
- • Provide input for clinical studies to assure compliance with domestic and international regulatory requirements (GCP)
- • Assist Director in negotiations with the FDA or other regulatory agencies for assigned projects.
- • Perform Regulatory intelligence and notify organization of updated information regarding worldwide laws, guidelines, and standards.
- • Other duties, as assigned.
Bachelor's Degree with a minimum of 4-years regulatory affairs or a minimum of 2-year regulatory affairs with Master’s Degree
- • History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.
- • Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
- • Regulatory Affairs Certification (RAC) preferred, but not required
- • Excellent organizational, multitasking, and communication skills
- • Proficiency with MS Office Suite and Adobe Acrobat Professional
Physical Demands and Conditions Requirements
- • General office environment.
- • Potential for domestic and international travel up to 15%.
- General office, respective laboratory, and device manufacturing equipment.