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13 days old

Device Engineer

Kelly Services
Gaithersburg, MD 20898
Kelly Services is currently seeking **Device Engineer** **for** one of our top clients in **G** **aithersburg, MD** .


**JOB TITLE:** **Device Engineer**


**INDUSTRY:** BioPharmaceutical


**WORK LOCATION: Gaithersburg, MD -** some flexibility to work remotely occasionally


**DURATION:** 12 Months (Temporary / Contract) **** **Extension Likely**


**JOB** **_DESCRIPTION:_**

Title: Device Engineer

Location: Gaithersburg, some flexibility to work remotely occasionally

Duration: 12 months, extension likely

Years of experience: 2-7


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. 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:**

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 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 collaborations

Drive a Quality mindset and ensure that work is performed in accordance with appropriate quality requirements and compliance standards (e.g. 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:

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. 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 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 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 collaborations Drive a Quality mindset and ensure that work is performed in accordance with appropriate quality requirements and compliance standards (e.g. 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.

Other Skills and Qualifications:

Excellent leadership skills to lead a cross functional team and ensure success of the project.

Experience in 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.


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 success of the project.

Experience in 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.


**Why Kelly?**


Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.


As a Kelly Services employee, you will have access to numerous perks, including:


+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career

+ Access to more than 3,000 online training courses through our Kelly Learning Center

+ Weekly pay and service bonus plans

+ Group-rate insurance options available immediately upon hire*


Let us help advance your career today.


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2022-06-13 Expires: 2022-07-14

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Device Engineer

Kelly Services
Gaithersburg, MD 20898

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