Product Development Engineer (164472) Job at A-Line Staffing Solutions LLC in Fr

R&D Senior Engineer – Specimen Management / Medical Devices

Location: Franklin Lakes, NJ

Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match.
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. xrczosw
• Experience supporting supplier development and component qualification.