Senior Design Engineer

Senior Design Engineer:

On behalf of our medical device industry client, Procom is searching for a Senior Design Engineer for a permanent role. This position is onsite at our client’s Deerfield Beach, Florida office.


Job Description:

The Senior Design Engineer will play a pivotal role in the development of advanced drug delivery systems, focusing on design, prototyping, analysis, and testing. This position involves collaborating with cross-functional teams to ensure designs meet user needs, regulatory requirements, and manufacturability standards.


Responsibilities:

• Lead design and development activities for drug delivery devices in accordance with design control processes
• Plan and execute testing for feasibility, characterization, and design verification
• Perform technical analyses, including statistical and tolerance analysis
• Conduct root cause investigations and implement corrective actions
• Support product commercialization and manufacturing scale-up efforts
• Collaborate with cross-functional teams including R&D, quality, regulatory, and manufacturing
• Communicate effectively with internal stakeholders and external partners
• Provide mentorship and technical guidance to team members
• Support regulatory documentation and submissions for combination products
• Participate in continuous improvement initiatives
  
  
  

Mandatory Skills:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field
• 4–7 years of experience in medical device design and development
• Proficiency in mechanical design (SolidWorks preferred)
• Experience with Finite Element Analysis (FEA)
• Strong background in statistical and tolerance analysis
• Knowledge of manufacturing processes, including injection molding
• Familiarity with risk management methodologies such as FMEA
  
  
  

Nice-to-Have Skills:

• Working knowledge of regulatory standards including 21 CFR Part 820, ISO 13485, ISO 11608, and ISO 14971
• Strong communication skills, both written and verbal
• Ability to exercise sound judgment and work effectively in a collaborative, global environment
• Demonstrates good cultural, social, and environmental awareness
• Experience in leading cross-functional teams
  
  
  

Assignment Length:

This is a permanent position.


Start Date:

ASAP.


Assignment Location:

Deerfield Beach, Florida, onsite.