Job Description
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.
