Mechanical Design Engineer
Prefer experience with medical plastic parts design, verification and validation. Specifically drug delivery system development and design. Will be working one of two projects- either development, design, testing and validation of nuclear medicine generator or prefilled syringes.
The Design Engineer is responsible for the design of drug / device combination products, from the research phase to the initial product launch. Strong emphasis in mechanical and materials design with added expertise in design controls and validation. Excellent cross functional team interaction. Initiative and drive to meet goals on time. Ability to thrive in a fast paced, dynamic product development environment. The Design Engineer is expected to have the appropriate background and experience in Computer Aided Design CAD . It is expected that the Design Engineer is capable of carrying out the design task with minimal supervision.
This is a 6 mo. contract with the potential to go longer and/or go permanent.
- Finds innovative solutions to problems at hand.
- Communicates effectively across multiple professional disciplines. This includes excellent technical writing and presentation skills.
- Adheres to customer and other marketing specifications, industry standards, quality and regulatory procedures and requirements; especially design controls
- Generates design output in the form of material specifications, drawings and 3D CAD models in Solidworks that are manufacturable, cost effective and robust.
- Generates design verification and validation test protocols and coordinates those activities.
- May perform support and sustaining activities for existing products.
- Generate test reports that are clear in hypothesis, procedure and conclusion.
- Professional at all times, in and outside the office environment.
BS or MS in Mechanical Engineering or Biomedical Engineering with mechanical emphasis.
Minimum 5 years experience in the development of medical devices / combination products.
- Working knowledge of low, medium and high volume medical grade fabrication methods and trends including molding, overmolding, materials selection, and new materials technology.
- Knowledge of FDA design control activities and design history files.
- Demonstrated experience generating and checking technical documentation such as design drawings, risk analyses, SOPs, DOEs, and test reports.
- Excellent organizational, interpersonal, technical writing and communication skills are required.
- Skilled in Computer Aided Design CAD software. SolidWorks 2008, ProEngineer, UG, AutoCAD
- Skilled in fixture and tooling design.
- Skilled in technical measurement using standard laboratory tools
- Knowledge of tolerance stackup methodology.
St. Louis, MO (relocation will be considered but not covered by client).
To apply email firstname.lastname@example.org
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