Senior Design Engineer

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

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents to our Talent Acquisition Department at RecruitUS@shl-group.com.
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