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Assoc R-D Engineer

Minneapolis, MN 55441

Posted: 06/07/2023 Employment Type: Contract Job Category: Engineering Job Number: 564620 Is job remote?: No Country: United States

Job Description

  1. Can you please confirm your top 3 skills sets required?
    1. CAD
    2. Experience with test method development and validation – performance of Gage Repeatability and Reproducibility or Measurement System Analysis studies
    3. Experience using statistical techniques – performance of ANOVA, Design of Experiments, and Monte Carlo simulations
  2. What is your target years of experience?  At least 1-year medical device industry experience.
  3. When do you plan to start interviewing? Pre-screening interviews week of May 22
  4. Will you be looking to hire and start ASAP or will the start date be delayed?  ASAP
  5. Will the contingent worker be working remotely or onsite, or both (if both, please confirm possible schedule)?  Hybrid, minimum 3 days a week on site but this can increase to 5 days a week when there is heaving testing (so individual should plan for potential of being onsite every day).  Likely schedule will be onsite Monday, Wednesday, Thursday (but may change as we are solidifying project team dates).

Careers That Change Lives

Engineers create our market-leading portfolio of innovations.  Join us to make a lasting impact. 

Design, develop and provide technical expertise in the research and development (R&D) of peripheral embolization medical devices from conception.  Support engineering teams through planning, prototyping, literature review, performing testing and analysis, and troubleshooting.  Partner with Quality, internal Manufacturing, Suppliers, Marketing, Regulatory Affairs, and other key functions to achieve business goals. 

This role is an individual contributor within the Peripheral Vascular Health operating unit, which employs the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.  We focus on transforming global vascular disease management.

A Day in A Life

As a R-D Engineer I you will focus on delivering R&D to new therapies, while adhering to policies using specialized knowledge and skills.   The role requires effective management and prioritization of multiple concurrent tasks in an ambiguous environment.  Responsibilities may include the following and other duties may be assigned:
  • Develop and coordinate small projects, as asked by the project team, with supervision from higher level engineering;
  • Assist in developing customer and product specifications;
  • Develop, troubleshoot, qualify, and/or validate fixtures, equipment, and test methods utilized to evaluate product design;
  • Assist in preparing engineering drawings with specifications and tolerances;
  • Create test plans/protocols, perform testing, and analyze and document results;
  • Process engineering change orders;
  • Assist in developing Failure Modes, Effects, and Criticality Analyses;
  • Present technical findings or task status to cross functional teams through meeting minutes, presentations, design reviews and other means of communication;
  • Perform job functions in accordance with applicable GMP and ISO standards;
  • Maintain required documentation per GDP procedures.

Must Have – Minimum Qualifications

Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required.

Nice to Have
  • Degree related to Biomedical Engineering, Mechanical Engineering, or Materials Science & Engineering;
  • Minimum 1 year experience in medical device industry with Class II or III product systems, preferably with vascular therapies, products and technologies (e.g. catheters, liquid embolics);
  • Experience with fixture, equipment, and test method development, especially for in-vitro clinical simulation testing of device performance (e.g. bench-top model).
  • Ability to compile, organize, and communicate technical data using Excel, Word, Visio, and PowerPoint;
  • Experience using common engineering software (e.g. CAD, Statistical – Minitab or JMP, MATLAB, PLM – Agile, Enovia or Windchill);
  • Experience using statistical techniques (e.g. DOE, Monte Carlo, ANOVA, Gage R&R, or Six Sigma tools and principles);

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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