Overview contract - 12 months with possible extension On site Monday -Thursday Friday remote We are seeking a highly motivated and innovative R&D Engineer to join our dynamic research and development team. In this role, you will be responsible for designing, developing, and testing new mechanical and electronic systems that advance our product offerings. The ideal candidate will possess a strong foundation in mechanical engineering principles, advanced skills in CAD modeling and simulation, and experience with manufacturing processes. This position offers an exciting opportunity to contribute to cutting-edge projects in a collaborative environment dedicated to technological innovation and product excellence. Responsibilities achelor's degree in Mechanical, Biomedical, Plastics, Chemical, or Materials Engineering, or a closely related engineering discipline. Minimum of 3 years of engineering experience in medical device product development, sustaining engineering, or design change engineering in an FDA-regulated environment. Working knowledge of design controls (FDA 21 CFR 820 and

ISO 13485

) and risk management (ISO 14971), including how design changes are assessed, documented, and verified. Hands-on experience writing and executing test protocols, developing test methods, and analyzing data with statistical tools such as Minitab or JMP. Strong engineering fundamentals for plastic and elastomeric components, assemblies, and packaging. Demonstrated ability to write clear, technically rigorous protocols and reports. Ability to manage several projects in parallel, lead through influence, and make sound recommendations with incomplete information. Clear, concise written and verbal communication, including presenting to both technical and leadership audiences.

PREFERRED QUALIFICATIONS

Experience with high-volume, single-use medical devices such as syringes, needles, catheters, or prefilled flush products. Experience evaluating material or supplier changes, including resin, elastomer, lubricant, or packaging material alternatives. Familiarity with standards relevant to medication delivery devices, such as

ISO 7886, ISO

80369, and

ISO 11607.

Experience building or supporting cost improvement business cases. Working knowledge of injection molding, insert molding and automated assembly sufficient to judge the manufacturability of a proposed change. Design of experiments (DOE) experience; Six Sigma Green Belt or Design for Six Sigma training. Experience with PLM, ERP, and document control systems such as SAP, Windchill, or Agile. Prior experience with Medication Delivery Solutions products or processes.

Pay:

$42.00 - $47.00 per hour Expected hours: 40.0 per week

Work Location:

In person