Medical Device Engineer - Senior
HTC Global Services wants you.
Come build new things with us and advance your career.
At HTC Global you'll collaborate with experts.
You'll join successful teams contributing to our clients' success.
You'll work side by side with our clients and have long-term opportunities to advance your career with the latest emerging technologies.
At HTC Global Services our consultants have access to a comprehensive benefits package.
Benefits can include Paid-Time-Off, Paid Holidays, 401K matching, Life and Accidental
Job Description:
The Senior Medical Device 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 the 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.
.
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 comply with applicable processes/procedures, standards and regulations, including Design controls, Risk management, Human factors engineering, FDA QSR, ISO13485, etc.
Major Duties and
Responsibilities:
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 pipeline.
Be a senior scientific contributor to complex problem solving and technical development.
Contribute to departmental combination product development capability by applying and maintaining a high level of knowledge and expertise.
Influence and educate cross-functional stakeholders and leaders on device development and commercialization best practices.
Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborationsDrive a Quality mindset and ensure that work is performed following appropriate quality requirements and compliance standards (eg risk management, Design Controls, ISO standards etc.
).
Contribute to regulatory filings and health authority responses.
Develop and implement best practices/business processes.
Requirements :
Education:
Engineering or technical degree or equivalent.
BS required MS or PhD preferred.
Experience:
Engineer:
A minimum of 2 years of experience in technical roles within combination product development.
Medical device experience.
Other Skills and
Qualifications:
Excellent leadership skills to lead a cross-functional team and ensure the success of the project.
Experience working with external development and commercialization partners and suppliers is highly desirable.
A track record of working effectively within a matrix organization with a highly cross-functional and collaborative environment is required.
Excellent communication skills are required.
Familiarity with industry standards and practices applicable to device and/or combination product development is required.
Compression molding.
Find a purposeHelp clients embrace emerging technologies.
Create inventive solutions and meet intriguing client challenges.
Solve, fix, design and innovate.
Be a part of something bigger by helping clients go digital, create engaging customer experiences and transform their business.
Move aheadOur success as a company is built on practicing inclusion and embracing diversity.
HTC Global Services is committed to providing a work environment free from discrimination and harassment, where all employees are treated with respect and dignity.
Together we work to create and maintain an environment where everyone feels valued, included, and respected.
At HTC Global Services, our differences are embraced and celebrated.
HTC is an Equal Opportunity Employer.
We respect and seek to empower each individual and support the diverse cultures, perspectives, skills and experiences within our workforce.
HTC is proud to be recognized as a National Minority Supplier.
About HTC Global ServicesShaping careers since 1990 - our long tenured employees are a testimony of the work culture.
Join our global employee base of 12,000 and help us bring human expertise to tech in order to deliver purposeful solutions that amplify value.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Come build new things with us and advance your career.
At HTC Global you'll collaborate with experts.
You'll join successful teams contributing to our clients' success.
You'll work side by side with our clients and have long-term opportunities to advance your career with the latest emerging technologies.
At HTC Global Services our consultants have access to a comprehensive benefits package.
Benefits can include Paid-Time-Off, Paid Holidays, 401K matching, Life and Accidental
Job Description:
The Senior Medical Device 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 the 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.
.
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 comply with applicable processes/procedures, standards and regulations, including Design controls, Risk management, Human factors engineering, FDA QSR, ISO13485, etc.
Major Duties and
Responsibilities:
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 pipeline.
Be a senior scientific contributor to complex problem solving and technical development.
Contribute to departmental combination product development capability by applying and maintaining a high level of knowledge and expertise.
Influence and educate cross-functional stakeholders and leaders on device development and commercialization best practices.
Establish a close working relationship with and provide effective oversight of suppliers and manage technical aspects of external collaborationsDrive a Quality mindset and ensure that work is performed following appropriate quality requirements and compliance standards (eg risk management, Design Controls, ISO standards etc.
).
Contribute to regulatory filings and health authority responses.
Develop and implement best practices/business processes.
Requirements :
Education:
Engineering or technical degree or equivalent.
BS required MS or PhD preferred.
Experience:
Engineer:
A minimum of 2 years of experience in technical roles within combination product development.
Medical device experience.
Other Skills and
Qualifications:
Excellent leadership skills to lead a cross-functional team and ensure the success of the project.
Experience working with external development and commercialization partners and suppliers is highly desirable.
A track record of working effectively within a matrix organization with a highly cross-functional and collaborative environment is required.
Excellent communication skills are required.
Familiarity with industry standards and practices applicable to device and/or combination product development is required.
Compression molding.
Find a purposeHelp clients embrace emerging technologies.
Create inventive solutions and meet intriguing client challenges.
Solve, fix, design and innovate.
Be a part of something bigger by helping clients go digital, create engaging customer experiences and transform their business.
Move aheadOur success as a company is built on practicing inclusion and embracing diversity.
HTC Global Services is committed to providing a work environment free from discrimination and harassment, where all employees are treated with respect and dignity.
Together we work to create and maintain an environment where everyone feels valued, included, and respected.
At HTC Global Services, our differences are embraced and celebrated.
HTC is an Equal Opportunity Employer.
We respect and seek to empower each individual and support the diverse cultures, perspectives, skills and experiences within our workforce.
HTC is proud to be recognized as a National Minority Supplier.
About HTC Global ServicesShaping careers since 1990 - our long tenured employees are a testimony of the work culture.
Join our global employee base of 12,000 and help us bring human expertise to tech in order to deliver purposeful solutions that amplify value.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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