Sr. Device Development Engineer

3 weeks ago

Durham, United States Automated Systems, Inc. Full time $135,500 - $144,000
Job DescriptionJob Description

Sr. Device Development Engineer 

Durham, NC - Hybrid Schedule

Potential for permanent hire

*Sponsorship is not available for this role now or in the future

 

Automated Systems, Inc. is actively seeking a Senior Device Development Engineer for one of our medical technology clients located in Durham, NC. The client specializes in device development platforms that enhance the safety and performance of single-use prefilled syringes.

 

Key Responsibilities:

·       Leads design and development activities and sustaining engineering activities related to device technology, including, but not limited to testing, design control activities, risk management activities, and change control.

·       Responsible for scoping, implementing and leading team projects/tasks. Works under only very general supervision. Work is reviewed for soundness of judgement and overall adequacy and accuracy

·       Create and maintain design history documentation in accordance with applicable regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, ISO 14971.

·       Provides support during regulatory inspections and customer audits.

·       Manage technical investigation teams as required by development activities.

·       Drive process and device improvements through characterization, testing, design of experiments, data analysis and simulation.

·       Development and validation of new test methods and characterization techniques with internal and external laboratories.

·       Plan and support human factors studies.

·       Execute statistical analysis using Minitab.

·       Ensure appropriate application of company policies and procedures for device development, risk management, test method development, statistical data analysis, and support of regulatory filings.

 

Education and Experience Requirements:

 

·       Bachelor’s degree or advanced degree in Engineering or Pharmaceutical Sciences. Master's degree is preferred.

 

·       5+ years of engineering experience, or equivalent with higher education, in relevant industry roles.

 

·       3+ years of engineering experience in medical device or pharmaceutical development.

 

·       Exposure to Injectables and Blow Fill Seal technology operations, preferred.

 

·       Deep understanding of the medical device regulatory environment and applicable regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, ISO 14971.

 

·       Knowledge of global industry standards (e.g. ISO, AAMI, ANSI, etc.).

 

·       Experience developing and commercializing regulated devices/combination products under Design Control (21 CFR 820 or ISO 13485) and ISO 14791 requirements.

 

·       Experience providing statistically sound guidance and justifications for design changes, qualification activities, and product release.

 

·       Driven, energetic, self-assured professional with high personal integrity; ability to develop effective, positive interpersonal relationships.

 

·       Able to initiate conversations to get the support/clarity necessary to carry out a task. Identifies the appropriate form of communication given the specific situation.

 

·       Proficient in MS Office Suite. (Project, Word, Excel, PowerPoint, Visio, Outlook)

 

·       Demonstrated problem solving ability.

 

Company DescriptionWe are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.Company DescriptionWe are a dynamic, project oriented consulting company offering individuals a wide variety of technical challenges. We are currently experiencing rapid growth, and are in need of talented individuals. ASI offers top wages and excellent benefits. ASI is an equal opportunity employer.

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