Medical Device Engineer
A$ A' A' ?Kelly is looking for Medical Device Engineer role at Gaithersburg MDTitle:
Medical Device EngineerLocation:
Gaithersburg, some flexibility to work remotely occasionallyDuration:
12 months, extension likelyYears of
Experience:
2-7The Engineer will lead or make strong technical contributions within cross functional combination product development teams and/or to complex technical development and problem-solving projects.
This role will be responsible for successful completion of design, development and commercialization deliverables and ensuring that device design, component selection, manufacturability and testing specifications and methods meet product needs.
To be successful the candidate must effectively interface with staff and leaders in Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering and across other areas of Biologics Product Development and Astra Zeneca.
Strong communication skills are required including succinct and effective presentation of technical and non-technical materials during meetings with company Senior Management / Leaders, health authorities, audits and other internal and external stakeholders.
This role will lead technical development with external development and commercialization partners and component suppliers and problem-solving activities using state of the art tools and techniques such as DMAIC, DFFS, DOE, Monte Carlo Simulation, Probabilistic Design, etc.
Development and commercialization must be conducted in compliance with applicable processes / procedures, standards and regulations including Design controls, Risk management, Human factors engineering, FDA QSR, ISO13485, etc.
Major Duties and
Responsibilities:
A cents EUR cents Lead or be a strong technical contributor to a cross functional team in the selection, development, scale up and/or commercialization of drug delivery devices for the AZ pipelineA cents EUR cents Be a senior scientific contributor to complex problem solving and technical developmentA cents EUR cents Contribute to departmental combination product development capability by applying and maintaining a high level of knowledge and expertiseA cents EUR cents Influence and educate cross-functional stakeholders and leaders on device development and commercialization best practicesA cents EUR cents Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborationsA cents EUR cents Drive a Quality mindset and ensure that work is performed in accordance with appropriate quality requirements and compliance standards (eg risk management, Design Controls, ISO standards etc.
)A cents EUR cents Contribute to regulatory filings and health authority responsesA cents EUR cents Develop and implement best practices / business processesRequirements :
Education:
A cents EUR cents Engineering or technical degree or equivalent.
BS required, MS or PhD preferred.
Experience:
The Engineer will lead or make strong technical contributions within cross functional combination product development teams and/or to complex technical development and problem-solving projects.
This role will be responsible for successful completion of design, development and commercialization deliverables and ensuring that device design, component selection, manufacturability and testing specifications and methods meet product needs.
To be successful the candidate must effectively interface with staff and leaders in Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering and across other areas of Biologics Product Development and Astra Zeneca.
Strong communication skills are required including succinct and effective presentation of technical and non-technical materials during meetings with company Senior Management / Leaders, health authorities, audits and other internal and external stakeholders.
This role will lead technical development with external development and commercialization partners and component suppliers and problem-solving activities using state of the art tools and techniques such as DMAIC, DFFS, DOE, Monte Carlo Simulation, Probabilistic Design, etc.
Development and commercialization must be conducted in compliance with applicable processes / procedures, standards and regulations including Design controls, Risk management, Human factors engineering, FDA QSR, ISO13485, etc.
Major Duties and
Responsibilities:
A cents EUR cents Lead or be a strong technical contributor to a cross functional team in the selection, development, scale up and/or commercialization of drug delivery devices for the AZ pipelineA cents EUR cents Be a senior scientific contributor to complex problem solving and technical development A cents EUR cents Contribute to departmental combination product development capability by applying and maintaining a high level of knowledge and expertiseA cents EUR cents Influence and educate cross-functional stakeholders and leaders on device development and commercialization best practices A cents EUR cents Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborations A cents EUR cents Drive a Quality mindset and ensure that work is performed in accordance with appropriate quality requirements and compliance standards (eg risk management, Design Controls, ISO standards etc.
) A cents EUR cents Contribute to regulatory filings and health authority responses A cents EUR cents Develop and implement best practices / business processesRequirementsEducation:
A cents EUR cents Engineering or technical degree or equivalent.
BS required, MS or PhD preferred.
Experience:
A cents EUR cents Engineer:
A minimum of 2 years of experience in technical roles within combination product development.
Other Skills and
Qualifications:
A cents EUR cents Excellent leadership skills to lead a cross functional team and ensure success of the project.
A cents EUR cents Experience in working with external development and commercialization partners and suppliers is highly desirable.
A cents EUR cents A track record of working effectively within a matrix organization with a highly cross-functional and collaborative environment is required.
A cents EUR cents Excellent communication skills are required.
A cents EUR cents Familiarity with industry standards and practices applicable to device and/or combination product development is required.
Engineer:
A cents EUR cents A minimum of 2 years of experience in technical roles within combination product development.
A cents EUR cents Medical device experienceOther Skills and
Qualifications:
A cents EUR cents Excellent leadership skills to lead a cross functional team and ensure success of the project.
A cents EUR cents Experience in working with external development and commercialization partners and suppliers is highly desirable.
A cents EUR cents A track record of working effectively within a matrix organization with a highly cross-functional and collaborative environment is required.
A cents EUR cents Excellent communication skills are required.
A cents EUR cents Familiarity with industry standards and practices applicable to device and/or combination product development is required.
A cents EUR cents Compression molding.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Medical Device EngineerLocation:
Gaithersburg, some flexibility to work remotely occasionallyDuration:
12 months, extension likelyYears of
Experience:
2-7The Engineer will lead or make strong technical contributions within cross functional combination product development teams and/or to complex technical development and problem-solving projects.
This role will be responsible for successful completion of design, development and commercialization deliverables and ensuring that device design, component selection, manufacturability and testing specifications and methods meet product needs.
To be successful the candidate must effectively interface with staff and leaders in Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering and across other areas of Biologics Product Development and Astra Zeneca.
Strong communication skills are required including succinct and effective presentation of technical and non-technical materials during meetings with company Senior Management / Leaders, health authorities, audits and other internal and external stakeholders.
This role will lead technical development with external development and commercialization partners and component suppliers and problem-solving activities using state of the art tools and techniques such as DMAIC, DFFS, DOE, Monte Carlo Simulation, Probabilistic Design, etc.
Development and commercialization must be conducted in compliance with applicable processes / procedures, standards and regulations including Design controls, Risk management, Human factors engineering, FDA QSR, ISO13485, etc.
Major Duties and
Responsibilities:
A cents EUR cents Lead or be a strong technical contributor to a cross functional team in the selection, development, scale up and/or commercialization of drug delivery devices for the AZ pipelineA cents EUR cents Be a senior scientific contributor to complex problem solving and technical developmentA cents EUR cents Contribute to departmental combination product development capability by applying and maintaining a high level of knowledge and expertiseA cents EUR cents Influence and educate cross-functional stakeholders and leaders on device development and commercialization best practicesA cents EUR cents Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborationsA cents EUR cents Drive a Quality mindset and ensure that work is performed in accordance with appropriate quality requirements and compliance standards (eg risk management, Design Controls, ISO standards etc.
)A cents EUR cents Contribute to regulatory filings and health authority responsesA cents EUR cents Develop and implement best practices / business processesRequirements :
Education:
A cents EUR cents Engineering or technical degree or equivalent.
BS required, MS or PhD preferred.
Experience:
The Engineer will lead or make strong technical contributions within cross functional combination product development teams and/or to complex technical development and problem-solving projects.
This role will be responsible for successful completion of design, development and commercialization deliverables and ensuring that device design, component selection, manufacturability and testing specifications and methods meet product needs.
To be successful the candidate must effectively interface with staff and leaders in Device Development, Quality, Regulatory Affairs, Drug Development, Process Engineering and across other areas of Biologics Product Development and Astra Zeneca.
Strong communication skills are required including succinct and effective presentation of technical and non-technical materials during meetings with company Senior Management / Leaders, health authorities, audits and other internal and external stakeholders.
This role will lead technical development with external development and commercialization partners and component suppliers and problem-solving activities using state of the art tools and techniques such as DMAIC, DFFS, DOE, Monte Carlo Simulation, Probabilistic Design, etc.
Development and commercialization must be conducted in compliance with applicable processes / procedures, standards and regulations including Design controls, Risk management, Human factors engineering, FDA QSR, ISO13485, etc.
Major Duties and
Responsibilities:
A cents EUR cents Lead or be a strong technical contributor to a cross functional team in the selection, development, scale up and/or commercialization of drug delivery devices for the AZ pipelineA cents EUR cents Be a senior scientific contributor to complex problem solving and technical development A cents EUR cents Contribute to departmental combination product development capability by applying and maintaining a high level of knowledge and expertiseA cents EUR cents Influence and educate cross-functional stakeholders and leaders on device development and commercialization best practices A cents EUR cents Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborations A cents EUR cents Drive a Quality mindset and ensure that work is performed in accordance with appropriate quality requirements and compliance standards (eg risk management, Design Controls, ISO standards etc.
) A cents EUR cents Contribute to regulatory filings and health authority responses A cents EUR cents Develop and implement best practices / business processesRequirementsEducation:
A cents EUR cents Engineering or technical degree or equivalent.
BS required, MS or PhD preferred.
Experience:
A cents EUR cents Engineer:
A minimum of 2 years of experience in technical roles within combination product development.
Other Skills and
Qualifications:
A cents EUR cents Excellent leadership skills to lead a cross functional team and ensure success of the project.
A cents EUR cents Experience in working with external development and commercialization partners and suppliers is highly desirable.
A cents EUR cents A track record of working effectively within a matrix organization with a highly cross-functional and collaborative environment is required.
A cents EUR cents Excellent communication skills are required.
A cents EUR cents Familiarity with industry standards and practices applicable to device and/or combination product development is required.
Engineer:
A cents EUR cents A minimum of 2 years of experience in technical roles within combination product development.
A cents EUR cents Medical device experienceOther Skills and
Qualifications:
A cents EUR cents Excellent leadership skills to lead a cross functional team and ensure success of the project.
A cents EUR cents Experience in working with external development and commercialization partners and suppliers is highly desirable.
A cents EUR cents A track record of working effectively within a matrix organization with a highly cross-functional and collaborative environment is required.
A cents EUR cents Excellent communication skills are required.
A cents EUR cents Familiarity with industry standards and practices applicable to device and/or combination product development is required.
A cents EUR cents Compression molding.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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