Senior Design Engineer

SHL Group; Deerfield Beach (FL); On-site; USD 90,000 - 130,000; Full time

Job summary

SHL Group is seeking a Senior Design Engineer to carry out development activities for medical devices, including design, prototyping, analyses and testing. The role involves cross-functional collaboration to ensure designs meet user needs, quality requirements and manufacturability, with >10% travel.

You will support regulatory filings for combination products and communicate with customers and manufacturing teams, contributing to design controls and robust product development within a global

Qualifications

• 4-7 years of experience.
• BS Mechanical Engineering/BS Biomedical Engineering.
• Proficient at mechanical design (Solidworks preferred).
• Proficient at technical analyses including statistical analysis and tolerance analysis.
• Proficient at performing Finite Element Analysis.
• Knowledge of manufacturing processes including injection molding.
• Knowledge of risk management processes including FMEA.
• Knowledge of regulations and standards including: 21 CFR Part 820, ISO 13485, ISO 11608, ISO 14971.
• Proficient at oral and written communication.
• Demonstrates good judgment as well as cultural, social, and environmental awareness.

Responsibilities

• Execute design and development of drug delivery devices following design controls.
• Plan testing for characterization, design feasibility, and Design Verification.
• Perform technical analyses including statistical analysis and tolerance analysis.
• Lead root cause investigations.
• Support commercialization and scale-up efforts.
• In a non-supervisory capacity, provide guidance and coaching to team.

Skills

4-7 years exp

Mechanical design

Statistical analysis

Tolerance analysis

Finite element analysis

Injection molding

FMEA

Regulatory standards

Communication

Risk management

Education

BS Mechanical Engineering

BS Biomedical Engineering

Tools

SolidWorks

Job description

Job Overview

Reporting to the Development Manager, the Senior Design Engineer carries out development activities for medical devices, including design, prototyping, technical analyses, and testing. The Senior Design Engineer collaborates closely with cross-functional project teams to ensure that designs meet user needs, quality requirements, and consider manufacturability. The Senior Design Engineer will communicate directly with customers and manufacturing teams and will be required to travel >10% of the time. The Senior Design Engineer will also support regulatory filings for combination products.

Main Responsibilities

• Execute design and development of drug delivery devices following design controls
• Plan testing for characterization, design feasibility, and Design Verification
• Perform technical analyses including statistical analysis and tolerance analysis
• Lead root cause investigations
• Support commercialization and scale-up efforts
• In a non-supervisory capacity, provide guidance and coaching to team

Skills and Qualification

• 4-7 years of experience
• BS Mechanical Engineering/BS Biomedical Engineering
• Proficient at mechanical design (Solidworks preferred)
• Proficient at technical analyses including statistical analysis and tolerance analysis
• Proficient at performing Finite Element Analysis
• Knowledge of manufacturing processes including injection molding
• Knowledge of risk management processes including FMEA
• Knowledge of regulations and standards including: 21 CFR Part 820, ISO 13485, ISO 11608, ISO 14971
• Proficient at oral and written communication
• Demonstrates good judgment as well as cultural, social, and environmental awareness

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast-growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization