R&D Engineer (164475)

Job Title: R&D Engineer Location: Franklin Lakes, NJ Work Schedule: Monday–Friday, 9:00 AM – 5:00 PM Pay Rate: $65.97/hour Position Overview As part of the Specimen Management business, the Staff Engineer, Product Development will be a key contributor to the R&D team, supporting the Specimen Acquisition Platform under the Enterprise Cost-To-Win (eCTW) program. This role requires broad and deep technical expertise, strong project leadership skills, and the ability to communicate effectively across technical teams and senior leadership. The engineer will support both existing products and new product development within the medical device and IVD space, with a strong focus on design control, cost improvement, and risk-based decision-making. Key Responsibilities Lead and support design and development of medical device and IVD products related to the collection, preservation, manipulation, and analysis of biological samples, including human blood samples. Drive design control activities, including design changes, documentation, verification, validation, and compliance with quality system requirements. Support and lead material, design, and process changes for existing products with a focus on cost savings and continuous improvement. Provide technical leadership on major programs and function as a project or technical lead as required. Apply risk-based engineering approaches, including sampling plans, statistical analysis, and Design of Experiments (DOE). Design, develop, and execute test methods, test fixtures, and benchtop studies; perform tolerance stack-ups, root cause analysis, and troubleshooting. Perform data analysis using statistical tools and clearly communicate findings, risks, and recommendations to peers and senior leadership. Collaborate cross-functionally with Quality, Manufacturing, Regulatory, Supply Chain, and external vendors. Represent the organization as a technical subject matter expert on projects and external engagements. Support R&D strategy development by evaluating new technologies, product concepts, and business opportunities. Ensure compliance with BD quality policies, procedures, and applicable regulatory standards. Required Qualifications Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field with 8+ years of experience; or Master’s degree with 5+ years of experience; or PhD with 3+ years of experience. Industry experience in orthopedic devices, life sciences, medical devices, or IVD products. Strong experience with design control processes in a regulated medical device environment. Demonstrated project management experience with the ability to clearly communicate scope, risks, timelines, and results. Proven ability to communicate effectively with senior leadership and across multiple organizational levels. Strong understanding of statistics, risk assessment, and sampling plans. Preferred Skills and Experience Proficiency in 3D CAD modeling (Creo, SolidWorks, or equivalent). Experience with high-volume, tightly controlled manufacturing processes. Knowledge of Design for Manufacturability (DFM) and Design for Six Sigma (DFSS). Proficiency with statistical tools such as Minitab and methods including DOE and MSA. Experience with fixture design, hands-on testing, and basic machining considerations. Familiarity with FEA and/or CFD modeling tools. Knowledge of Six Sigma DMAIC methodologies. Core Competencies Strong technical judgment, critical thinking, and systematic problem-solving skills. Ability to independently develop and execute technical solutions to complex problems. Strong organizational, prioritization, and multitasking skills. Excellent written and verbal communication skills. Demonstrated drive for results, accountability, and continuous improvement. If you are interested, please send an up-to-date resume to

jschafer@alinestaffing.com