Position : Mechanical Test Engineer

Location : Research Triangle Park, NC

Duration : 12 Months

Total Hours/week : 40.00

1^st Shift

Client: Medical Devices Company

Job Category: Engineering

Level Of Experience: Mid-Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

Job Description:

Basic Summary:

• Please focus on Test Engineers
• Also please focus on Biomedical experience
• The Client Translation and Clinical Sciences Center of Excellence (TCS-COE) is looking for a talented and disciplined Senior Engineer responsible for development and execution of test methods to characterize device performance and qualify equipment/processes as part of the TCS-COE team.
• The successful candidate will have a high level of accountability and responsibility for technical leadership and planning to achieve project deliverables, including generating creative solutions to complex technical problems. This position will coordinate with colleagues to assess device functional performance through bench, preclinical, and clinical evidence generation.
• The individual should have a proven track record of functionality across a broad range of scientific fields that spans in vitro and in vivo research (i.e. engineering, biology) with expertise in drug delivery device evaluation.
• This is an individual contributor position where the incumbent will own significant project responsibilities for effective translational development of medical technologies from numerous business units and segments across the client R&D portfolio.

• The ideal candidate will need to have a demonstrated track record of technical achievement as an individual contributor as well as an aptitude for technological communication to both internal and external stakeholders.
• This person should have a professional background in biotechnology and medical device design with a strong working knowledge of engineering design, computational modeling, analytical techniques, biology, and human physiology to solve multidisciplinary biomedical problems.

Essential Duties and Responsibilities:

• Apply engineering principles and methods to understand and provide solutions to complex technical challenges.
• Translation of objectives/goals into an actionable time bound plan, allowing for contingencies
• Ability to define problems, create respective experimental designs, and collect, interpret, and analyze data using statistical techniques to draw valid conclusions
• Identify the best tools and approaches to develop/optimize device and system designs using an appropriate mix of first principles / analytical, computational and experimental methods.
• Drive design and development of novel engineering and clinically relevant simulated use test methods/systems for bench and preclinical device performance evaluations
• Conduct experiments to characterize device performance and biomechanics of tissue response including developing test method and measurement system qualifications, fixture design, and testing optimization
• Develop and execute assembly methods, tooling, equipment and processes for devices and supporting data acquisition systems intended for preclinical and clinical evaluations
• Demonstrate excellent understanding of medical device product development stages including risk management methodologies
• Ability to effectively create 3D engineering models, assemblies, fixtures, and drawings
• Drive design and development of prototype/research device systems, subsystem and components by understanding design space options and tradeoffs, managing critical parameters, using design for manufacture principles as well as geometric dimensioning and tolerancing tools.
• Understand manufacturing and prototype fabrication methods and their applications (Injection Molding / Sheet Metal / Machined components / stereolithography / polyjet / DMLS / FDM etc
• Provide timely, accurate and reliable reporting on progress against key measures and goals
• Generate detailed, accurate, and compliant engineering documentation, reports, and presentations.
• Effectively work in a QA controlled documentation environment that contributes to Design History Files
• Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
• Work cross-functionally with R&D, medical affairs, marketing, quality, regulatory and operations as needed to establish program goals and meet deliverables
• Actively participate in team ideation sessions with other team members and participate in periodic design reviews of projects
• Identify and understand customer needs and relationship to device design through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies.
• Collaborate with internal/external stakeholders in generating creative, effective and practical solutions
• Communicate effectively through both verbal presentation and technical writing to numerous internal (BD business units) and external stakeholders of varying technical abilities.
• Identify and coordinate strategic outsourcing of design/analysis and QC activities. Manage external resourcing through drafting of legal agreements and time bound statements of work.

Qualifications:

• Education: Bachelor’s degree (B.S.) or equivalent in appropriate engineering discipline (biomedical, mechanical, chemical, others considered) or science discipline (chemistry, biology, physics). Advanced MS or PhD degree is preferred.
• Experience: 4 years of experience in technology and/or product development.

• Proficiency with SolidWorks, or other equivalent 3D modeling software.
• Experience in both experimental design and data analysis using Python, Matlab, JMP, Prism or other similar tools.
• Excellent attention to detail and the ability to prioritize and work on multiple projects in a fast-paced environment.
• Strong technical aptitude with the ability to learn new concepts and tools quickly.
• Strong technical writing and verbal communication skills.
• Experience with performing device and process root cause analysis
• Ability to plan, prepare, perform and monitor preclinical testing to evaluate in vivo device function
• Apply best practices in design, drawings, assembly and test documentation using appropriate QA standards and methods to support design history files and other regulatory requirements for GMP device qualification and clinical testing
• Ability to work effectively within the project team and the cross-functional organization
• Molded part design, simulation, animations, or finite element analysis a plus
• Working knowledge with biological samples and BSL2 environment a plus
• Ability to work quickly, efficiently, and virtually as needed.