Kelly Services Medical Device Engineer in Gaithersburg, Maryland
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting 12+ month, long term contract opportunity as a Medical Device Engineer for a top fortune 500 company in Gaithersburg MD.
Title: Medical Device Engineer
Duration: 12+ months
Location: Gaithersburg MD
Essential Duties and Responsibilities:
The candidate for this position will be part of client’s Dosage Form 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 mechanical and electro-mechanical delivery 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 technology assessment, biocompatibility assessment, and additional assessments as needed.
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
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.
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.
Education / Experience:
BS, MS, or PhD degree in Mechanical/Electrical/Biomedical/Chemical Engineering, Physics, Pharmaceutical Sciences, or related field.
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.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Michelle Niemira ( firstname.lastname@example.org ) for immediate consideration.
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
A competitive hourly pay rate with weekly checks
Access to newly expanded Medical Plan options
Online continuing education via the Kelly Learning Center
Several employee discounts
Why Kelly ® ?
As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just 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 , we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.