They are currently looking for additional workers to make their new MagSense™ superparamagnetic relaxometry (SPMR) machine...
Job description
Job Overview
Imagion Biosystems has developed a proprietary technology for the highly sensitive detection of magnetic nano-particles linked to antibodies, or other biologically active moieties, for the in vivo detection of cancer, and other human diseases. The Director of Engineering will be responsible for the engineering design and development efforts of related to all Imagionthe Company’s instrumentation products, including current products and products under development. This is a “hands-on” role involving engineering design and testing both internally Internal and through external engineering resources. Responsibilities will be applied to span the entire product life cycle from conception through prototype, production, and in-field service, to standards, to be which are compliant with the applicable regulatory requirements for medical devices based on this proprietary technology. Products require the role be comfortable with and competent to direct disciplines of mechanical, electrical, biochemical, computer science and software engineering.
Primary Duties and Responsibilities
Participate in setting Company short and long term plans for product development and introduction to market
Drive the process of defining top level and detailed product requirements specifications, working with senior and marketing management
Undertake research design, development, and testing efforts to establish product specification parameters
Coordinate engineering efforts with scientific staff and outsideinternal and external scientific resources to ensure product engineering will be compatible with and make optimal use of the applicable enabling scientific principles and meet customer requirements
Implement the appropriate level of engineering required by the product requirement specification for each product during development, initial production and in-field performance
Oversee in-house engineering activities and recruit and employ outside engineering resources as needed to meet Company time, quality, and budget requirements
Manage engineering resources “from within”, performing direct engineering tasks as needed
Coordinate mechanical, electrical, biochemical, and computer hardware and software engineering to ensure technical and schedule compatibility and meeting cost targets
Organize and conduct cross discipline design reviews to ensure overall engineering synchronization
Responsible for the preparation of all documentation and test protocols to satisfy medical device regulatory requirements, including FDA clearance/approval, the Medical Device Directive, ISO 13485, medical device manufacturing standards, etc.
Responsible for manufacturing engineering to enable employment of in-house manufacturing or a CMO, including tooling design, assembly procedures, quality assurance test protocols
Qualifications
Minimum of a Bachelor’s Degree in mechanical or electrical engineering preferred, engineering technology or biotechnology acceptable
Minimum ten years related engineering experience, preferably in hands-on medical devicein design, development and manufacturing of one or more complex products, preferably medical devices currently on the market
Demonstrated experience in successful project management from concept to product
Self-starter able to manage multiple concurrent tasks, including management of people (both directly and indirectly) with diverse technical specialties and diverse personalities
Thorough understanding of mechanical and electrical engineering principles, basic software engineering, and design requirements for electromechanical products, preferably and biochemical based medical devices and bio-interactive technologies
Comprehension and respect for the science underlying the Company’s mission and a desire to drive the commercialization of that science
Personal CharacteristicsQualifications
To be successful, the Director of Engineering must bring professional and personal values to the company which complement the company’s existing team including:
Creativity and critical intellect
Dedication to respect, diligence, honesty, and transparency
A lead-by-example mentality
Works with a continual sense of urgency and to inspire team members and others in the Company to do the same
Must have strong written, verbal and interpersonal skills to work with a variety of employees and collaborators at differing levels
Additional Requirements
This position is located in Albuquerque, NM
This position requires travel 10-20% of the year
At times, will be required to lift an average of 40+lbs
Seniority Level
Director
Industry
Biotechnology Medical Devices
Employment Type
Full-time
Job Functions
Engineering Project Management
Job description
Job Overview
Imagion Biosystems has developed a proprietary technology for the highly sensitive detection of magnetic nano-particles linked to antibodies, or other biologically active moieties, for the in vivo detection of cancer, and other human diseases. The Director of Engineering will be responsible for the engineering design and development efforts of related to all Imagionthe Company’s instrumentation products, including current products and products under development. This is a “hands-on” role involving engineering design and testing both internally Internal and through external engineering resources. Responsibilities will be applied to span the entire product life cycle from conception through prototype, production, and in-field service, to standards, to be which are compliant with the applicable regulatory requirements for medical devices based on this proprietary technology. Products require the role be comfortable with and competent to direct disciplines of mechanical, electrical, biochemical, computer science and software engineering.
Primary Duties and Responsibilities
Participate in setting Company short and long term plans for product development and introduction to market
Drive the process of defining top level and detailed product requirements specifications, working with senior and marketing management
Undertake research design, development, and testing efforts to establish product specification parameters
Coordinate engineering efforts with scientific staff and outsideinternal and external scientific resources to ensure product engineering will be compatible with and make optimal use of the applicable enabling scientific principles and meet customer requirements
Implement the appropriate level of engineering required by the product requirement specification for each product during development, initial production and in-field performance
Oversee in-house engineering activities and recruit and employ outside engineering resources as needed to meet Company time, quality, and budget requirements
Manage engineering resources “from within”, performing direct engineering tasks as needed
Coordinate mechanical, electrical, biochemical, and computer hardware and software engineering to ensure technical and schedule compatibility and meeting cost targets
Organize and conduct cross discipline design reviews to ensure overall engineering synchronization
Responsible for the preparation of all documentation and test protocols to satisfy medical device regulatory requirements, including FDA clearance/approval, the Medical Device Directive, ISO 13485, medical device manufacturing standards, etc.
Responsible for manufacturing engineering to enable employment of in-house manufacturing or a CMO, including tooling design, assembly procedures, quality assurance test protocols
Qualifications
Minimum of a Bachelor’s Degree in mechanical or electrical engineering preferred, engineering technology or biotechnology acceptable
Minimum ten years related engineering experience, preferably in hands-on medical devicein design, development and manufacturing of one or more complex products, preferably medical devices currently on the market
Demonstrated experience in successful project management from concept to product
Self-starter able to manage multiple concurrent tasks, including management of people (both directly and indirectly) with diverse technical specialties and diverse personalities
Thorough understanding of mechanical and electrical engineering principles, basic software engineering, and design requirements for electromechanical products, preferably and biochemical based medical devices and bio-interactive technologies
Comprehension and respect for the science underlying the Company’s mission and a desire to drive the commercialization of that science
Personal CharacteristicsQualifications
To be successful, the Director of Engineering must bring professional and personal values to the company which complement the company’s existing team including:
Creativity and critical intellect
Dedication to respect, diligence, honesty, and transparency
A lead-by-example mentality
Works with a continual sense of urgency and to inspire team members and others in the Company to do the same
Must have strong written, verbal and interpersonal skills to work with a variety of employees and collaborators at differing levels
Additional Requirements
This position is located in Albuquerque, NM
This position requires travel 10-20% of the year
At times, will be required to lift an average of 40+lbs
Seniority Level
Director
Industry
Biotechnology Medical Devices
Employment Type
Full-time
Job Functions
Engineering Project Management
