Engr 2, Product Development

• R D Project Engineer (Medical Devices)

Location:

Franklin Lakes, NJ | Contractor | On-site Mon-Thu, Remote Fri |

Bill Rate:

$50

• 62.

50/hr About the Role Join an innovative Sustaining Engineering team responsible for the technical appraisal and advancement of cost-saving design changes to high-impact medical devices. As the R D Project Engineer, you will drive the feasibility analysis, risk assessment, and business case development for design modifications on critical products like syringes, needles, and vascular care solutions. This hands-on, high-visibility role directly influences product quality, operational efficiency, and cost competitiveness within a fast-paced, FDA-regulated environment. Responsibilities

• Own the end-to-end technical evaluation of proposed changes to released products, from intake through feasibility, appraisal, and recommendation
• Define project-critical assumptions and develop rapid, credible test plans to validate or refute them
• Execute feasibility testing, including prototyping, bench, and comparative performance assessments
• Analyze test results using robust statistical methods; develop and refine test methods and protocols
• Assess impacts on drawings, specifications, BOMs, labeling, and regulatory documentation
• Lead risk assessment activities and updates (dFMEA/pFMEA, ISO 14971), collaborating with Quality and Regulatory teams
• Outline verification/validation strategies and estimate scope, cost, and timing for execution-phase testing
• Build and validate business cases, documenting technical and financial appraisal outcomes for leadership decisions
• Present clear go/no-go recommendations and project status at technical reviews and prioritization forums
• Coordinate cross-functional input from Quality, Regulatory, Medical Affairs, Procurement, and suppliers
• Deliver execution-ready project packages and maintain status visibility within portfolio tracking systems
• Ensure compliance with design control, risk management, and all BD safety and quality requirements Required Skills and Experience
• Bachelor's degree in Mechanical, Biomedical, Plastics, Chemical, or Materials Engineering (or similar)
• 3+ years of engineering experience in medical device product development or sustaining engineering (FDA-regulated)
• Proficient in design controls (FDA 21 CFR 820, ISO 13485), risk management (ISO 14971), and technical documentation
• Hands-on test protocol development and execution, with strong statistical data analysis (Minitab, JMP)
• In-depth knowledge of plastics, elastomers, assemblies, and medical device packaging
• Exceptional written and verbal communication; able to present to both technical and executive audiences
• Proven ability to manage multiple projects, lead through influence, and make sound recommendations under ambiguity Preferred Skills
• Experience with high-volume, single-use medical devices (syringes, needles, catheters, flush products)
• Evaluating material and supplier alternatives (resins, elastomers, lubricants, packaging)
• Familiarity with

ISO 7886, ISO 80369, ISO 11607

standards

• Cost improvement business case development
• Manufacturing process knowledge (injection molding, insert molding, automated assembly)
• Design of Experiments (DOE), Six Sigma Green Belt or DFSS training
• Experience with PLM/ERP/document control systems (SAP, Windchill, Agile)
• Prior experience with BD Medication Delivery Solutions products/processes Benefits
• Hybrid work schedule: On-site Mon-Thu, remote Fridays
• Exposure to high-impact projects with direct leadership visibility
• Opportunity to influence the product portfolio of a global medical device leader
• Collaborative, cross-functional work environment
• Professional growth in sustaining engineering, risk management, and regulatory affairs How to Apply Submit your resume and a brief cover letter detailing your relevant experience and interest in cost-driven product engineering for medical devices.

Qualified candidates will be contacted for next steps. (JSON format)