Job Description:

Terms of EmploymentMaking sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.W2 Contract-to-PermanentThe initial contract period prior to converting permanently would be six months.This position is 100% onsite in the Port Covington neighborhood of Baltimore, Maryland.OverviewOur client is developing a point of care diagnostics platform that automates a PCR Assay on a disposable cartridge. The Senior Mechanical Engineer will help finalize the design of the NDx instrument, documenting and verifying the design, and transferring the design to manufacture. This is an excellent opportunity to get in early with a start-up that is generating sizeable funding from interested investors.ResponsibilitiesUse 3D modeling (SOLIDWORKS) to perform design iterations to the Novel Dx instrument and consumable. Confirm design performance and optimization through testing.Perform design analysis and implement design changes for ease of manufacturing and assembly.Maintain documentation of the design requirements and design changes.Develop and maintain design history file. Prepare documentation and transition to production.Create and maintain Manufacturing/Engineering drawings and Bill of Materials.Work closely with manufacturing collaborators, team members and consultants to establish a manufacturing process for the components. Required Skills & ExperienceBachelor's degree and 6+ years of experience in mechanical engineering related to responsibilities specified.High proficiency in 3D CAD (SOLIDWORKS) with experience building of electro-mechanical systems and complex mechanisms (PCB boards, wiring of connectors, lead screws, etc.).Ability to prototype components using prototyping tools like 3D printers, CNC mill, LASER cutters and other machine shop tools.Experience with design for plastic injection molding.Experience with design for manufacture and assembly.Experience with creating and maintaining a design history file.Preferred Skills & ExperienceExperience in mechanical design and development of medical devices, with a strong understanding of relevant regulations and standards such as FDA 21 CFR Part 820, ISO 13485.Ability to draw conclusions and make recommendations based on research data and findings.Ability to communicate effectively, both orally and in writing.Ability to use independent judgment to develop model concepts and approaches for research.Ability to conduct systematic analysis and develop solutions to complex scientific problems.Knowledge of engineering and/or scientific research principles, practices, and protocols.