R&d Engineer

Device Engineer II

Our client is seeking a hands-on Medical Device Engineer to support the design, development, and commercialization of complex catheter-based medical devices. This role is ideal for engineers with experience in new product development who can drive technical solutions, collaborate across functions, and contribute throughout the product lifecycle.

Key Responsibilities

+ Design and develop catheter-based devices and delivery systems from concept through commercialization.

+ Translate user and product requirements into innovative engineering solutions.

+ Create and maintain 3D CAD models, drawings, and specifications using Solid Works or similar software.

+ Build, test, and refine prototypes through hands-on development and performance evaluation.

+ Lead or support design verification testing, test method development, and simulated-use studies.

+ Partner with Manufacturing, Quality, and Operations teams to develop scalable, robust production processes.

+ Support Design for Manufacturability (DFM) initiatives, including catheter assembly, bonding, braiding, thermoforming, laser processing, and related manufacturing methods.

+ Maintain design control documentation, including DHF, risk management, testing protocols, and engineering changes.

+ Participate in design reviews, root cause investigations, CAPA activities, and product improvement efforts.

+ Ensure compliance with FDA regulations, ISO standards, and company quality requirements.

+ Provide technical mentorship and guidance to junior engineers as needed.

Required Qualifications

+ Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or related field.

+ 3+ years of medical device product development experience (5+ years preferred).

+ Strong experience designing and developing complex catheter systems, including:

+ Multi-lumen shafts

+ Braided or coil-reinforced catheters

+ Laser-cut hypotubes and torque transfer systems

+ Balloon catheter integration

+ Multi-material catheter construction

+ Knowledge of catheter materials, adhesives, bonding methods, and manufacturing processes.

+ Proficiency with Solid Works or comparable 3D CAD software.

+ Hands-on experience with prototyping, testing, and engineering analysis.

+ Working knowledge of design controls, risk management, ISO 13485, ISO 14971, and FDA quality system requirements.

+ Strong problem-solving, analytical, and communication skills.

Preferred Qualifications

+

Experience with steerable or deflectable catheter systems.

+ Experience in cardiovascular, structural heart, or aortic devices.

+ Expertise in catheter manufacturing processes such as braiding, laser processing, bonding, reflow, tipping, and thermoforming.

+ Experience supporting manufacturing transfer and production scale-up.

+ Familiarity with statistical analysis and test method development.

Job Type & Location

This is a Contract to Hire position based out of Charlotte, NC.

Pay and Benefits

The pay range for this position is $38.46 - $72.11/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

- Medical, dental & vision
- Critical Illness, Accident, and Hospital - 401(k) Retirement Plan
- Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability
- Health Spending Account (HSA) - Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Charlotte,NC.

Final date to receive applications

This position is anticipated to close on Sep 4, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a Clearly Rated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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