Job Description

Job Title: Design Engineer

Department: Product Development

Location: Deerfield Beach, FL

Direct hire, full benefits from day 1

Salary: $80-95000/yr base

Relocation: $5000 assistance

Industry: Medical Device

1st Shift

Job Overview:

Kelly Engineering Services is hiring a Design Engineer on behalf of a leading medical device manufacturer in Deerfield Beach, FL. This role focuses on the development of drug delivery devices, such as autoinjectors and combination products. The engineer will contribute to design, prototyping, technical analysis, and testing. You will work cross-functionally with teams in quality, regulatory, and manufacturing to ensure product designs meet user needs, industry standards, and are production-ready.

This position involves direct communication with internal teams and manufacturing groups in Taiwan.

Responsibilities:

• Design and develop drug delivery devices in accordance with design control regulations
• Plan and execute testing for design feasibility, characterization, and design verification
• Conduct technical analyses, including statistical and tolerance analysis
• Lead or participate in root cause investigations for design issues
• Support product commercialization and scale-up efforts
• Collaborate with cross-functional teams, including regulatory, quality, and manufacturing
• Assist with regulatory filings for combination products

Qualifications:

Required:

• Bachelor’s degree in Mechanical Engineering or similar
• 2–4 years of relevant engineering experience, willing to consider candidates in automotive and aerospace
• Proficiency with mechanical design tools (SolidWorks preferred)
• Strong technical writing and documentation skills
• Proficiency with Microsoft Office suite
• Excellent communication and decision-making abilities

Preferred:

• Experience with statistical and tolerance analyses
• Familiarity with industry regulations such as:
• 21 CFR Part 820
• ISO 13485
• ISO 14971
• ISO 11608
• Knowledge of injection molding and design for manufacturability (DFMA)
• Experience with FMEA and risk management processes
• Proficiency with Finite Element Analysis (FEA)
• Hands-on experience with root cause analysis in a regulated environment

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