Product Development Engineer (164472)

R&D Senior Engineer – Specimen Management / Medical Devices Location: Franklin Lakes, NJ Rate: $55–$60/hr on W-2 Duration: Long-term contract Position Overview We are seeking an experienced R&D Senior Engineer to serve as a key contributor within a Research & Development team supporting a Specimen Management / Specimen Acquisition Platform . This role requires advanced engineering expertise, strong technical judgment, and the ability to independently solve complex product development challenges in a regulated medical device environment. The ideal candidate works under general direction, determines technical approaches independently, contributes to projects of significant impact, and may lead smaller-scope initiatives. This position plays a critical role in design, testing, verification, validation, and risk-based product development. Key ResponsibilitiesProduct Development & Technical Leadership Contribute to R&D projects of considerable scope or lead smaller engineering initiatives. Independently determine and develop technical approaches to solve complex engineering problems. Apply sound engineering principles to deliver imaginative, practical, and data-driven solutions. Support material, design, and process changes through formal design control processes , ensuring timely and successful completion of assigned work. Design, Testing & Validation Design and develop in vivo and in vitro models to evaluate product features and improvements. Plan, execute, and analyze Design of Experiments (DOE) . Develop robust test methods, design test fixtures, and perform Measurement System Analysis (MSA) . Execute and document bench studies, tolerance stack-up analyses, design verification, and validation activities. Support vendor interactions, materials selection, and component specifications. Data Analysis & Reporting Perform statistical analysis, regression analysis, and develop transfer functions. Collect, record, interpret, and analyze experimental data. Prepare technical reports and present findings to peers and business leadership. Provide advanced engineering input to support business cases for new product opportunities. Quality & Compliance Ensure compliance with quality system requirements, policies, and procedures. Apply risk-based development approaches aligned with medical device regulations. Promote quality awareness and sound engineering practices across the team. Cross-Functional Collaboration Participate in and lead technical, DFSS, design, and cross-functional reviews. Direct associates and lead small cross-functional groups when required. Collaborate with manufacturing, quality, supply chain, and external partners. Required Knowledge & SkillsEngineering & Technical Expertise Strong knowledge of engineering first principles . Proven technical judgment and problem-solving abilities. Experience with R&D functional planning, requirement generation, and technical reviews across all product development phases. Proficiency with solid modeling tools such as Pro/ENGINEER (Creo), SolidWorks , or equivalent. Proficiency in fixture design , basic machining considerations, and test method development. Understanding of high-volume, tightly controlled manufacturing processes . Methodologies & Quality Systems Strong understanding of Six Sigma (DMAIC) and Design for Six Sigma (DFSS) methodologies. Knowledge of Measurement Systems Analysis (MSA) . Experience working within phase-gate product development processes . Project & Leadership Skills Strong project management, prioritization, and multitasking skills. Ability to work independently with minimal direction. Experience leading small cross-functional teams or directing associates. Proficiency with Microsoft Project or similar project planning tools. Communication Excellent written and verbal communication skills. Ability to clearly communicate technical concepts, risks, and recommendations to diverse audiences. Preferred Qualifications Experience in the medical device or life sciences industry . Hands-on experience with statistical tools and experimental analysis software. Experience supporting supplier development and component qualification.