Research Development Project Engineer

R&D Project Engineer – Medical Devices | Sustaining Engineering

Location: Franklin Lakes, NJ 07417 (Hybrid)

Pay Rate: $42–$48/hour (Depending on Experience)

Duration: 12 Months (Contract, Possible Extension)

Work Schedule: Onsite Monday–Thursday | Remote Friday

We are seeking an experienced R&D Project Engineer – Medical Devices to lead technical feasibility assessments, design change evaluations, and cost improvement initiatives for an established medical device product portfolio in Franklin Lakes, New Jersey .

This opportunity with a Fortune 250 global medical technology company focuses on sustaining engineering, product testing, FDA design controls, risk management, and engineering change management for medical devices, including syringes, needles, and prefilled flush products.

Relocation Assistance: Not Available

Work Authorization: NO Visa Sponsorship / No H1Bs / No C2Cs

Position Overview

The R&D Project Engineer will support the Medication Delivery and Vascular Care (MDVC) Sustaining Engineering program by serving as the technical lead for evaluating proposed design changes to existing medical devices.

This role will assess the feasibility of material substitutions, component modifications, packaging changes, and supplier changes while maintaining product safety, quality, regulatory compliance, and performance.

The ideal candidate will bring hands-on medical device engineering experience, strong knowledge of FDA design controls, technical testing expertise, and the ability to lead cross-functional engineering projects from feasibility evaluation through execution readiness.

Key Responsibilities

1. Sustaining Engineering & Technical Feasibility

• Lead technical feasibility assessments for proposed design changes and cost improvement projects involving existing medical devices.
• Evaluate material, component, packaging, and supplier changes, including alternate resins, lubricants, elastomers, and outsourced components.
• Define critical engineering assumptions and develop testing strategies to validate proposed changes.
• Plan and execute feasibility studies, prototype builds, bench testing, and comparative product performance testing.
• Develop, troubleshoot, and execute test methods, including test fixture design, measurement equipment selection, and measurement systems analysis.
• Analyze experimental data using statistical tools such as Minitab or JMP to support technical recommendations.

2. Medical Device Design Controls, Risk Management & Compliance

• Assess engineering change impacts on drawings, specifications, Bills of Materials (BOMs), labeling, and Design History Files (DHF).
• Collaborate with Quality and Operations teams on design and process risk assessments, including dFMEA, pFMEA, and ISO 14971 activities.
• Develop preliminary design verification and validation (V&V) strategies for proposed engineering changes.
• Evaluate testing requirements involving biocompatibility, sterilization, packaging, shelf life, and product performance.
• Partner with Regulatory Affairs to assess the regulatory implications of proposed design modifications.
• Ensure compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, applicable quality procedures, and safety requirements.

3. Engineering Cost Reduction & Project Evaluation

• Evaluate product design changes intended to reduce manufacturing or material costs without compromising safety, quality, or performance.
• Partner with Finance, Procurement, and Manufacturing teams to develop engineering cost improvement business cases.
• Assess projected savings, implementation costs, capital requirements, timelines, and technical risks.
• Document technical feasibility findings through the MDVC Project Feasibility Appraisal Review process.
• Present engineering findings and go/no-go recommendations to technical teams and leadership.
• Prepare technical reports covering feasibility testing, assumptions, risks, results, and recommendations.
• Identify technically or financially unviable projects early in the evaluation process.

4. Cross-Functional Engineering & Project Management

• Coordinate engineering activities with Quality, Regulatory Affairs, Medical Affairs, Procurement, Supplier Quality, Sterilization, Packaging Engineering, and Manufacturing.
• Work with suppliers to obtain samples, technical specifications, and supporting documentation.
• Develop execution-ready project packages, including scope, risk assessments, testing strategies, resource estimates, and schedules.
• Manage multiple engineering projects while tracking progress, technical risks, and milestones.
• Support the handoff of approved engineering projects to execution teams.

Required Qualifications

Education

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics Engineering, Chemical Engineering, Materials Engineering, or a closely related engineering discipline.

Experience & Technical Skills

• Minimum 3 years of engineering experience in medical device product development, sustaining engineering, or design change engineering within an FDA-regulated environment.
• Strong understanding of medical device design controls, including FDA 21 CFR 820 and ISO 13485.
• Working knowledge of ISO 14971 risk management and engineering change control processes.
• Hands-on experience developing and executing test protocols, test methods, and engineering feasibility studies.
• Experience analyzing experimental data using statistical tools such as Minitab or JMP.
• Strong engineering fundamentals involving plastic components, elastomers, assemblies, and packaging materials.
• Experience preparing technical protocols, test reports, engineering documentation, and design change assessments.
• Ability to manage multiple projects, collaborate across departments, and make sound technical recommendations.
• Strong written and verbal communication skills, including presenting technical findings to engineering and leadership teams.

Preferred Qualifications

• Experience with high-volume, single-use medical devices, including syringes, needles, catheters, or prefilled flush products.
• Experience evaluating material substitutions, supplier changes, and engineering cost reduction initiatives.
• Familiarity with medical device standards, including ISO 7886, ISO 80369, and ISO 11607.
• Experience developing or supporting engineering cost improvement business cases.
• Knowledge of injection molding, insert molding, and automated assembly processes.
• Experience with Design of Experiments (DOE), Six Sigma Green Belt, or Design for Six Sigma methodologies.
• Familiarity with PLM, ERP, and document control systems such as SAP, Windchill, or Agile.
• Previous experience with BD Medication Delivery Solutions products or manufacturing processes.

Why Consider This Opportunity?

• Work with an established Fortune 250 global medical technology organization.
• Contribute to sustaining engineering and product improvement initiatives involving widely used medical devices.
• Gain exposure to technical feasibility assessments, medical device design controls, product testing, and cross-functional engineering decision-making.
• Hybrid work arrangement in Franklin Lakes, NJ.

Interested in This Opportunity?

Qualified candidates with experience in medical device sustaining engineering, R&D product development, engineering change control, and technical feasibility testing are encouraged to apply.

Recruiter Contact Info

Sajag Bhardwaj

Email: [email protected]

www.ameritconsulting.com

I'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Company Overview:

Amerit Consulting is a nationwide staffing and consulting firm supporting Fortune 500 clients across healthcare, technology, engineering, and professional services. With over 2,000 employees across 47 states, Amerit specializes in contract, temporary, and direct hire staffing solutions.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.