Senior Mechanical Engineer

Karen Borresen

Engineer
Burnsville, MN
Posted 1 month ago

Imricor is the first and only company in the world to bring cardiac catheter ablation products into the MRI environment during real-time scanning. We are growing quickly- looking for strong employees to join our team and help bring this therapy to patients all over the world. At Imricor, we are committed to fostering a diverse and inclusive workforce to fulfill our Mission.

Basic Function

The Senior Mechanical Engineer is responsible for the design and development of disposable catheter products to ensure a successful production launch.  This position will be focused on designing devices that meet customer requirements based on input from research, marketing, quality, regulatory, and manufacturing departments. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Responsibilities

  • Utilize established engineering principles in the design and evaluation of mechanical components.
  • lead design and development plans to design, prototype, and refine concepts using engineering principles, human factors/usability, and design for manufacturability practices.
  • Consults and solicits feedback from internal stakeholders to identify customer needs and translate these requirements into the designs. In addition, provides support regarding product development to internal departments as it relates to mechanical design.
  • Create prototypes and conduct testing to ensure design performs as expected.
  • Work with suppliers and manufacturing departments to ensure final design is properly realized based on the design intent.
  • Works cooperatively on project team with design assurance, quality, manufacturing, regulatory, clinical, and marketing to ensure the successful launch of products through the product development process.
  • Create and execute change orders to document and implement changes.
  • Evaluate and manage cost of goods sold (COGS) of designs.
  • Define and setup product in electronic document control software.
  • Use SolidWorks to create and interpret prints, technical drawings, and schematics.
  • Prepare and present technical information to a technical audience.
  • Provides training and work direction as required to technicians and junior engineers.
  • Demonstrates knowledge of product development process system knowledge through delivery of high-quality deliverables.
  • Perform other related duties and responsibilities as assigned.

Qualifications

  • BS in Mechanical Engineering
  • Minimum 5 years of product development experience
  • Knowledge of FDA, GMP, and ISO 13485; any experience with QSR implementation is desired, but not required
  • Experience designing product utilizing SolidWorks required
  • Experience with Microsoft Office: Word, Excel, PowerPoint
  • Proven hands-on work experience and driven work ethic
  • Strong verbal and written communication skills
  • Must be able to work independently with limited supervision.
  • Demonstrated project management experience

Working Conditions

  • Light work, exerting up to 20 lbs. of force or less.
  • Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
  • Requires finger dexterity, repetitive motion, talking and hearing.
  • 85% of time requires viewing and working at computer screen.
  • Significant work pace & pressure due to deadlines.
  • Travel 10%

Imricor is an equal opportunity employer and encourages diverse candidates to apply.

To apply, please submit your resume and cover letter documents below.

Job Features

Job CategoryEngineering
Position reports to:Engineering Manager
Position Status:Exempt

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