Avails Medical Inc
Senior Systems Engineering Manager
Avails Medical Inc, Menlo Park, California, United States, 94029
SENIOR SYSTEMS ENGINEERING MANAGERREPORTS TO:
VP of EngineeringESSENTIAL JOB FUNCTIONS / RESPONSIBILITIES:Responsible for providing technical direction and system level expertise for the design, development, and sustaining of Avails electronic IVD products including electrical sensors, embedded systems, algorithms, hardware, software, and associated disposable cartridges.Facilitate cross functional decision making on technical decisions.Participates in technical development strategy for the project.Lead integration of product technologies with respect to mechanical, electrical, firmware and software, consumables.Develops concepts, prototypes, products, and manufacturing solutions by working with all company production units.Ability to prepare Systems Engineering cost and schedule estimates on major design development efforts.Works with internal/external partners as necessary to leverage key capabilities as needed for the project.Creates protocols and performs System Evaluation and Verification Activities.Guides design, definition and updates of system requirements, system specifications, input/output processes and working parameters by using systems engineering best practices.Manages the design, build-out, out-sourcing, and/or testing of critical sub-systems.Documents system requirements by writing documents, reports, memos, change requests. Methods used are determined by approved procedures and standards.Tracks system engineering effort by creating and maintaining records in the approved tracking management tool.Prepares studies to analyze new and existing systems.Translate experimental results into design criteria.Interfaces directly with management team on project status/issues.Mentors engineers in engineering activities/methodologies and domain knowledge.Coordinates system testing including evaluation, validation & verification activities.Participates and guides in the Risk Analysis discussions for the project.Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow and work processes.Support the design review and phase gate process to ensure that engineering deliverables are at the appropriate level to meet FDA/ISO requirements & standards.EDUCATION REQUIREMENTS:PhD or Master's Degree in Electrical, Mechanical, Chemical or Biomedical Engineering or related field with a minimum of 7 years experience.Bachelor degree with 10+ years of experience in an R&D Engineering role.EXPERIENCE REQUIREMENTS:Recent experience in the medical device industry is strongly preferredA minimum of 8 years of management experience.Strong team leadership and group management skills, with ability to effectively prioritizeEffective communicator both across and outside the organization.Experience creating a climate of innovation and helping managers understand innovation preferred. Understanding of the patent process preferred.Proven success in driving system development.Must be a good team builder who can effectively and efficiently grow the organization to meet business goals.REQUIRED SKILLS / QUALIFICATIONS:Proven experience in leading complex system analysis from concept through commercialization.Medical Device industry experience in design controls with a focus on user needs, intended use, system requirements, system design and traceability.Experience designing and building high-accuracy, high-reliability systems.Familiar with systems verification/validation.Ability to Negotiate contracts with partnering and consulting firms to perform research and other applicable studies.PERSONAL TRAITS:Self-motivated with a passion for solving problems.Strong communication skills (verbal & written).Passion for urgently developing scalable solutions to fight infectious diseases.Comfort with problems you haven't encountered before, energized by the challenge of solving them.Ability to effectively interact with a broad and diverse range of colleagues.Creativity and ability to think critically about unfamiliar problemsDedication to getting the job done, no matter how big or small.Compassion and respect for teammates, and a passion for helping those around you.Passion for new technologiesTRAVEL REQUIREMENTS:Comfortable with a dynamic, flexible travel schedule, comfortable traveling abroad or in the United States on short notice.Up to 25% of time.
VP of EngineeringESSENTIAL JOB FUNCTIONS / RESPONSIBILITIES:Responsible for providing technical direction and system level expertise for the design, development, and sustaining of Avails electronic IVD products including electrical sensors, embedded systems, algorithms, hardware, software, and associated disposable cartridges.Facilitate cross functional decision making on technical decisions.Participates in technical development strategy for the project.Lead integration of product technologies with respect to mechanical, electrical, firmware and software, consumables.Develops concepts, prototypes, products, and manufacturing solutions by working with all company production units.Ability to prepare Systems Engineering cost and schedule estimates on major design development efforts.Works with internal/external partners as necessary to leverage key capabilities as needed for the project.Creates protocols and performs System Evaluation and Verification Activities.Guides design, definition and updates of system requirements, system specifications, input/output processes and working parameters by using systems engineering best practices.Manages the design, build-out, out-sourcing, and/or testing of critical sub-systems.Documents system requirements by writing documents, reports, memos, change requests. Methods used are determined by approved procedures and standards.Tracks system engineering effort by creating and maintaining records in the approved tracking management tool.Prepares studies to analyze new and existing systems.Translate experimental results into design criteria.Interfaces directly with management team on project status/issues.Mentors engineers in engineering activities/methodologies and domain knowledge.Coordinates system testing including evaluation, validation & verification activities.Participates and guides in the Risk Analysis discussions for the project.Continuously improves process and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow and work processes.Support the design review and phase gate process to ensure that engineering deliverables are at the appropriate level to meet FDA/ISO requirements & standards.EDUCATION REQUIREMENTS:PhD or Master's Degree in Electrical, Mechanical, Chemical or Biomedical Engineering or related field with a minimum of 7 years experience.Bachelor degree with 10+ years of experience in an R&D Engineering role.EXPERIENCE REQUIREMENTS:Recent experience in the medical device industry is strongly preferredA minimum of 8 years of management experience.Strong team leadership and group management skills, with ability to effectively prioritizeEffective communicator both across and outside the organization.Experience creating a climate of innovation and helping managers understand innovation preferred. Understanding of the patent process preferred.Proven success in driving system development.Must be a good team builder who can effectively and efficiently grow the organization to meet business goals.REQUIRED SKILLS / QUALIFICATIONS:Proven experience in leading complex system analysis from concept through commercialization.Medical Device industry experience in design controls with a focus on user needs, intended use, system requirements, system design and traceability.Experience designing and building high-accuracy, high-reliability systems.Familiar with systems verification/validation.Ability to Negotiate contracts with partnering and consulting firms to perform research and other applicable studies.PERSONAL TRAITS:Self-motivated with a passion for solving problems.Strong communication skills (verbal & written).Passion for urgently developing scalable solutions to fight infectious diseases.Comfort with problems you haven't encountered before, energized by the challenge of solving them.Ability to effectively interact with a broad and diverse range of colleagues.Creativity and ability to think critically about unfamiliar problemsDedication to getting the job done, no matter how big or small.Compassion and respect for teammates, and a passion for helping those around you.Passion for new technologiesTRAVEL REQUIREMENTS:Comfortable with a dynamic, flexible travel schedule, comfortable traveling abroad or in the United States on short notice.Up to 25% of time.