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22 days old

Medical Device Design Engineer

Kelly Services
Gaithersburg, MD 20898
**Medical Device Design Engineer**


Kelly is seeking a talented **Medical Device Design Engineer** for our biotechnical manufacturing client in Gaithersburg, MD. The ideal candidate will have a Bachelors degree in Mechanical, Biochemical Engineering, Biomedical Engineering or related discipline with at least 3-5 years of medical device engineering. Additionally, the candidate will require strong knowledge in change control familiarity and regulations and standards. This a 3-6-month contract position with potential for extension or direct hire for the right person!


*** MUST BE ABLE TO WORK AS AN EMPLOYEE (ON W-2 BASIS) *** NO C2C, 1099, etc. ***


+ Location: On site but will consider hybrid (remote/onsite) schedule. Candidate must be local to the area at time of application

+ Schedule: Monday Friday, 8:00 AM 5:00 PM

+ Pay commensurate with experience


**Summary of the group:**


The Device Development Group is responsible for design, development, healthcare authority approval and ultimately launch of drug/device combination products. The product portfolio is mainly focused on subcutaneous drug delivery system, and also have several new Technology Development projects in other related areas.


**In this role you will:**


+ Be a high functioning technical and collaborative member of cross functional CMC and device development teams to meet program deliverables

+ Apply engineering principles with minimal oversight in the design and development of robust devices and drug/device combination products

+ Independently solve complex problems using tools such as: engineering modelling and simulation tools, design and prototyping tools, statistical analysis, benchtop experiments and analysis, usability engineering tools, design for manufacturability/assembly techniques and design for six sigma.

+ Have a strong working knowledge and experience with regulations and standards such as design controls, risk management, human factors and industry standards specific to an individuals discipline

+ Identify and effectively communicate potential design/process problems, analyses problems following best practices, provides practical solutions and manages the consequences of any failures

+ Represent the Function internally as well as externally with CMOs and development partners.


**Education & Skills**


+ Bachelors degree in Mechanical, Biochemical Engineering, Biomedical Engineering or related discipline with at least 3-5 years of service in engineering related role within Medical Device.

+ Experience and thorough understanding of medical device development

+ Demonstrated experience of product characterization, design controls and risk management

+ Extensive experience of working in a cross functional product development environment

+ Excellent communication skills (both written and oral) to summarize development work, critical conclusions and its relevance to the bigger picture

+ Demonstrated experience in one or several of the following areas: new technology development, process development, combination product development, human factors, test methods development, device/process characterization, design controls, risk management

+ Fully competent in device development.

+ Strong knowledge of regulations and standards such as design controls, risk management, human factors and industry standards specific to an individuals subject area (e.g. risk management, Design Controls, FDA QSR, ISO13485, ISO standards etc.)

+ Change control familiarity.

+ Will be able to work without direct supervision and be able to advise/ train less experienced engineers.


**Desired Skills** :


+ Experience in development of drug/device combination products for subcutaneous delivery

+ Technical leadership of cross-functional development teams


**Why Kelly?**


As a Kelly employee, youll have access to world-class perks, including:


+ Kelly-sponsored Affordable Care Act health care coverage available to eligible employees

+ *Group insurance options

+ Service bonus plan

+ Holiday pay plan

+ Weekly electronic pay options

+ Online training campus that provides more than 3,000 free courses to help improve and develop skills

+ Exclusive online employee community

+ Employee assistance program available at no cost

+ Corporate discounts

+ Transportation Spending Accounts


*Offered and administered by Leslie & Associates. These plans are not sponsored by Kelly Services.


**Apply Today!**


*Important information: This position is recruited by a remote, national, Kelly office, NOT your local Kelly branch. Applicants must be legally permitted to work in the United States.


**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.
Posted: 2022-05-02 Expires: 2022-06-04

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Medical Device Design Engineer

Kelly Services
Gaithersburg, MD 20898

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