R&d Engineer

Description

Our client is seeking a highly motivated Medical Device Engineer with strong experience in the design and development of complex catheter-based medical devices. The ideal candidate will possess deep technical knowledge of catheter design, materials, and manufacturing processes, along with the ability to collaborate cross-functionally within a fast-paced medical device development environment.

Responsibilities:

• Participate in and/or lead the design and development of complex catheter-based medical devices and delivery systems.
• Develop innovative design concepts and translate product requirements into functional engineering solutions.
• Create detailed 3D CAD models, engineering drawings, assemblies, and technical specifications using SolidWorks or equivalent CAD platforms.
• Perform engineering analysis including tolerance stack-ups, material selection, mechanical characterization, and performance evaluations.
• Build, refine, and troubleshoot prototype devices through hands-on bench development and iterative testing.
• Lead or support design verification activities including DV planning, development of test methods, protocol generation, and execution of mechanical and simulated-use testing.
• Collaborate with Operations, Tooling, Quality, and Manufacturing Engineering teams to develop robust and scalable manufacturing processes.
• Support Design for Manufacturability (DFM) initiatives related to catheter assembly, braiding, bonding, thermoforming, laser processing, and other specialized manufacturing techniques.
• Prepare and maintain Design History File (DHF) documentation including design inputs, design outputs, risk management files, protocols, reports, and engineering change documentation.
• Translate user needs, physician feedback, and clinical requirements into actionable engineering design inputs and specifications.
• Participate in design reviews, technical discussions, and project planning activities to support program milestones and deliverables.
• Support root cause investigations, CAPA activities, and product/process improvement initiatives.
• Ensure compliance with applicable FDA regulations, ISO standards, and company Quality System requirements.
• Mentor junior engineers and provide technical guidance where applicable.
• Perform other duties as assigned in support of engineering and business objectives.

Additional Skills & Qualifications

• Bachelor's or Master's degree in Biomedical Engineering, Mechanical Engineering, or a related engineering discipline.
• Minimum of 3 years of medical device product development experience; 5+ years preferred.
• Strong experience in the design and development of complex catheter systems, including one or more of the following:
• Multi-material composite catheter construction
• Multi-lumen shaft design
• Coil reinforcement structures
• Torque transfer systems including braids and laser-cut hypotubes
• Balloon integration and attachment methods
• Strong understanding of catheter materials including hypotubes, nitinol, polymer shafts, braids, coils, adhesives, and bonding processes.
• Proficiency with 3D CAD software, preferably SolidWorks.
• Demonstrated hands-on experience building prototypes, performing mechanical testing, and interpreting performance data.
• Experience identifying and supporting appropriate catheter manufacturing processes and assembly methods.
• Working knowledge of design controls, risk management, ISO 14971, ISO 13485, and 21 CFR Part 820.
• Familiarity with applicable medical device standards including ISO 10555, ISO 11070, ISO 5840, ISO 25539, and related standards.
• Strong analytical, problem-solving, and troubleshooting skills.
• Effective verbal and written technical communication skills.
• Preferred Qualifications
• Experience with steerable or deflectable catheter systems.
• Experience with complex multilumen shaft constructions or devices incorporating imaging, ablation, or therapeutic technologies.
• Hands-on experience with catheter manufacturing processes including braiding, laser processing, bonding, reflow, tipping, and thermoforming.
• Experience developing devices for structural heart, cardiovascular, or aortic applications.
• Experience supporting transfer to manufacturing and production scale-up activities.
• Familiarity with statistical analysis tools and engineering test method development.

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

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)

This is a fully onsite position in Charlotte,NC.

This position is anticipated to close on Aug 31, 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 ClearlyRated 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.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.