Senior Combination Products Engineer

2 weeks ago


North Chicago, Illinois, United States Collins Consulting Full time

This position requires onsite presence. Candidates must be US Citizens or Green Card holders.

Contractor Engineer for Combination Products

Overview
The Contractor Engineer for Combination Products operates under technical guidance within project teams focused on combination products and medical devices. Responsibilities encompass contributing to product design documentation and executing laboratory assessments of product performance to support product development, manufacturing transitions, supplier-driven design modifications, and product enhancements. The products are designed for drug delivery and include disposable and implantable plastic products, injection devices, and electromechanical devices with integrated software. All work adheres to device design controls (FDA 21CFR820.30 and/or applicable ISO standards). Additionally, the role involves developing product knowledge through initiatives that include understanding existing competitive products in the market, materials research, and computer simulations.

Key Responsibilities and Objectives:

  • Conduct independent laboratory experiments and data analysis with a focus on mechanical testing.
  • Analyze documentation and prepare technical transfer documents.
  • Create technical documentation for products under development.
  • Prepare design change documentation for current products.
  • Design, develop, and construct experimental fixtures/jigs in collaboration with vendors.
  • Troubleshoot experiments and instrumentation.
  • Acquire and comprehend new experimental techniques.
  • Exhibit proficiency in various techniques and adjust protocols as necessary.
  • Contextualize data appropriately by consulting and referencing relevant literature.
  • Demonstrate technical expertise in medical device performance characterization.
  • Comply with corporate standards regarding conduct, safety, medical device design controls, and GxP compliance.
Major Responsibilities:
Expertise Level:
  • Proficient in technical transfers and design control principles for medical devices.
  • Experienced with documentation management systems.
  • Skilled in CAD, design principles, GDT, and data management systems.
  • Competent in laboratory environments with an emphasis on mechanical testing.
  • Familiar with rapid prototyping technologies and equipment.
  • Capable of working in a regulated environment.
  • Knowledgeable about lab safety practices and Electronic Notebook usage.
  • Acquainted with tool room environments, metrology, and CMM principles.
  • Applies basic computer skills for data analysis.
  • Utilizes technical writing skills to produce protocols, reports, and other documentation.
Leadership Activities:
  • Operates under the direction of senior staff.
  • Summarizes and presents project results to project teams.
  • Capable of training other staff members on experimental methods, protocol procedures, and manufacturing techniques.
  • Independently conducts laboratory studies and suggests enhancements to laboratory capabilities and processes.
Interpersonal Skills:
  • Functions effectively in a team environment.
  • Collaborates with others on design and data analysis.
  • Able to present work to small groups.
Qualifications:
Basic Requirements:
  • Experience in medical device design with CAD and GDT.
  • Familiarity with SolidWorks is advantageous.
  • Experience in laboratory settings.
  • Knowledge of safety practices and scientific documentation.
  • Proficient technical writing skills.
  • Ability to develop, troubleshoot, and execute experiments with technical instrumentation.
  • Previous experience in a regulated environment, preferably in medical devices.
  • Strong communication skills, both written and verbal.
Education:
  • Bachelor's Degree or equivalent in Biomedical, Mechanical, Chemical Engineering, Materials Science, or a related field with 5+ years of experience.
  • Master's Degree or equivalent in Biomedical, Mechanical, Chemical Engineering, Materials Science, or a related field with 3+ years of experience.


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