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25 days old

Engineering Support Specialist

Kelly Services
Gaithersburg, MD 20898
**Job Details:**



**Industry:** Biopharmaceutical



**Work Location:** Gaithersburg, MD



**Job Title:** Engineering Support Specialist



**Duration:** 12 Months (Temporary/Contract)




**_Engineering Support Specialist Gaithersburg, MD_**



Kelly Services is currently seeking a **Engineering Support Specialist** for one of our top clients in **Gaithersburg, MD** .





**JOB DESCRIPTION:**



The candidate for this position will be part of the Design and Development group working on combination product development, development of novel technologies, and transforming scientific knowledge / analysis into practical implementations.


The candidate will identify, evaluate, and develop solutions for digital connectivity integration (internal and external) within mechanical and electro-mechanical delivery systems. Digital connectivity integration will integration of mechanical and electronic systems. Desirable for candidate to have previous experience with mechanical engineers and mechanical device experience as well as experience working with electronics engineers and electronics systems.


Under minimal supervision, the candidate will manage and accomplish assigned projects in a timely fashion and to agreed quality standards. Apply knowledge and expertise to take responsibility for ensuring appropriate and robust test methods are developed and qualified in support of device development projects. Proactive in proposing innovative ideas and solving complex problems.


Establish and champion best practices for test method qualification, ISO functionality device testing, and participate in general assessment for biocompatibility assessment.


Hands on development and qualification of device test methods, fixtures, and custom accessories (which may be electromechanical in nature). Author technical reports and process descriptions as required. Be an accomplished user of Solidworks or similar CAD tool and be an accomplished user of device testing instruments such as INSTRON tensile test machine, Mitutoyo QVX302 optical measurement system, Lansmont transportation simulator, and other engineering tools. Develop process descriptions to standardize testing procedures.


Be able to design, develop and execute DOE experiments for device characterization. Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOPs, protocols, and reports with minimum supervision. Assess and report data with a clear understanding of its reliability, interpret findings and draw authoritative conclusions and recommendations so that their significance can be appreciated. Present findings at internal/external meetings, prepare manuscripts and patent applications.


Establish and maintain a close working relationship with equipment vendors and contribute to oversite of external collaboration partners. Liaise effectively with internal departments (Quality, Regulatory, Operations, etc).


Manage the transfer of developed test methods to internal and external quality control testing sites. Plan and manage device DV and stability testing.


Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. ISO/ASTM/MDD/GMP/GLP, 21CRF820.30 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards. Prepare formal reports and contributions to regulatory documentation.


Keep the various process description documents up to date and contribute to the tech transfer documentation as required. Present data at the team and Department meetings as required. Maintain and contribute to Quality Systems 21 CFR820.30 and ISO 13485 within the group to ensure consistency and conformance with GxP working practices



**Position Requirements:**

Requires understanding and experience of the principles and concepts within the area of device development in the pharmaceutical industry and is expected to demonstrate up to date technical knowledge.


Knowledge of relevant compliance systems and experienced in authoring relevant sections in regulatory submissions (IND, IMPD, BLA, MAA etc.).





**Position Requirements:**

Requires understanding and experience of the principles and concepts within the area of device development in the pharmaceutical industry, and is expected to demonstrate up to date technical knowledge.


Knowledge of relevant compliance systems and experienced in authoring relevant sections in regulatory submissions (IND, IMPD, BLA, MAA etc.).


The candidate should have capability, skill and/or knowledge in one or more of the following areas:

Biopharmaceutical / combination drug product development

Combination product and cGMP regulations and standards

Practical laboratory working knowledge

Knowledge of laboratory equipment (e.g. Instron, QVX302, etc)

Design of fixtures, components, and assemblies using CAD (e.g. Solidworks or similar)

Design verification, experimental design, statistics, data analysis

Leadership and interpersonal communication

Technical writing and documentation

Cross functional collaboration

Prior experience with electro-mechanical drug delivery and/or medical device systems development a plus.


**Educational Requirements:**

BS, MS, or PhD degree in Mechanical/Electrical/Biomedical/Chemical Engineering, Physics, Pharmaceutical Sciences, or related field.


**Experience:** Suitable experience may include development of combination products / medical devices and/or associated testing activities. A high degree of self-motivation, engineering skill and technical rigor is required.



**Special Skill/Abilities**

Good communication skills and strong interpersonal skills are essential. Demonstrated leadership capabilities, organization, flexibility, and the ability to operate in a fast-paced environment are an integral part of this position. Strong work habits and commitment to the position are highly valued. Problem solving, a hands on scientific approach, innovation and creativity are also fundamental qualities for success in this role.


Candidate is expected to be an independent thinker and able to perform work responsibilities and determine technical objectives with minimal direction and guidance. Candidate is expected to be pro-active in identifying critical activities and prioritizing project tasks appropriately.




**Why Kelly?**

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*



**Apply Today!**







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



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**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. 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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS
Posted: 2020-07-13 Expires: 2020-08-13

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Engineering Support Specialist

Kelly Services
Gaithersburg, MD 20898

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