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Engineering Support Specialist

Kelly Services


Location:
Gaithersburg, MD
Date:
04/25/2018
2018-04-252018-05-24
Job Code:
US41L8DV_BH1427902
Categories:
  • Engineering
Kelly Services
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Job Details

Job Title Engineering Support Specialist

Jobid US41L8DV_BH1427902

Location: Gaithersburg, MD, 20898, USA

Description **Job Details:**

**Industry:** Biopharmaceutical

**Work Location:** Gaithersburg, MD

**Job Title:** Engineering Support Specialist

**Duration:** 6 Months (Temporary/Contract)
**_Engineering Support Specialist – Gaithersburg, MD_**

Kelly Services is currently seeking an **_Engineering Support Specialist_** for one of our top clients in **Gaithersburg, MD** .

**JOB DESCRIPTION:**

**Ideal Candidate Characteristics:**
**1 - Engineering degree**
**2 - Hands-on experience with INSTRON and Solidworks (at least 1 year)**
**3 - Medical device experience in a Pharma setting**
**4 - Prior 21CFR experience, Part 4 or A20 (medical device)**
**5 - GDP experience (good documentation practices)**

Be able to design, develop and execute DOE experiments for primary container and device characterization. Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, SOPs, protocols, and reports with minimum supervision. Present findings at internal meetings, prepare manuscripts and patent applications.

Be able to conceptualize, design, and develop novel solutions utilizing a combination of mechanical and electrical engineering techniques and knowledge. Meet and complete assigned task in timely and efficient manners.

Innovate, develop and evaluate primary container and device characterization techniques and technologies as they relate to combination product development requirements. Perform test method development, qualification and method transfer to GMP testing group in support of device verification & validation testing.

Be an accomplished user of device engineering and testing software/tool/equipment such as the Rap ID layer explorer, INSTRON tensile test machine, confocal and/or light microscopy, Cognex / Keyence vision system, Solidworks, Minitab, Labview, Matlab and etc. Develop process descriptions to standardize testing procedures across analysts.

Establish and maintain a close working relationship with internal departments and stakeholders.

Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. ISO/MDD/GMP/GLP, 21CRF Part 4 & 820.30 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards.

Assist where appropriate in the training of new members of the FS/DDDD group, particularly with the Instron test system.

**Position Requirements:**
Prior experience with medical device and/or combination product design and development.

Experience with Solidworks, Instron, Minitab, 3D printer, and microscopy

Prior experience working with prefilled syringes, autoinjectors, and/or other drug delivery devices is a plus.

Prior experience designing and/or developing electro-mechanical devices is a plus.

Knowledge of medical / combination device verification & validation is a plus.

**Educational Requirement:**
B.S. or M.S. degree in Mechanical/Biomedical/Electrical/ Materials/Chemical Engineering or related field.

**Experience Requirement:**
Prior industry experience in pharmaceutical/biotech/medical or drug delivery device or relevant Academic Lab a plus.

**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, innovation and creativity are also fundamental qualities for this role.

Candidate is expected to be an independent thinker and able to perform work responsibilities and determine technical objectives with minimal direction and supervision.

**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** **®** **?**


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

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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