R-D Engineer II - Exempt

Minneapolis, MN 55428

Posted: 07/02/2025 Employment Type: Contract Job Category: Engineering Job Number: 620849 Is job remote?: No Country: United States

Job Description


Additional position detail from the manager:
  1. Can you please confirm your top 3 skills sets required? Experience with 3D CAD modeling software is required (preferably Creo), experience with troubleshooting design issues is preferred, experience with writing design validation/verification protocols and reports is preferred.
  2. Can you please confirm the 3 main responsibilities/day to day activities required for this role? The primary responsibility for this role will be 2D and 3D modeling of components and finished goods within our Cardiac Surgery product portfolio. This could include updates to existing parts or modeling new parts from scratch. This position will also help troubleshoot design issues and implement improvements while meeting our design and quality system requirements. This includes understanding product requirements and how those translate into design specifications. This role will also create design protocols and reports to validate design changes.
  3. What products (if any) will this role support? This role will support our Cardiac Surgery products, with a focus on our injection molded products.
  4. What is your target years of experience? 2-10 years
Areas of responsibilities will include mechanical design, injection molding design and troubleshooting, design requirements, test requirements and test procedures. Candidates must be able to translate design inputs, write detailed specifications, generate and review design documentation, test specifications and test reports in compliance with design control procedures used within the medical device industry.  Candidates must also be willing to work in a fast paced, multi-tasking, team environment.
  • · Develop and evaluate designs which meet defined product requirements and that are optimized for producibility, reliability, and overall cost to the business.
  • · Work with cross functional teams to review, assess and implement design input for injection molded components. 
  • · Ability to troubleshoot design issues, particularly understand injection molding related issues (i.e., process, material, design intent).
  • · Responsible for product system design and ensuring that products developed meet both internal and external customer requirements.
  • · Conduct or direct the evaluation of designs against defined product requirements and ensure optimization for producibility, reliability, and overall cost to the business.   Document and support decisions using engineering analysis and data.
  • · Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements.
  • · Adhere to the applicable medical device FDA requirements for design and manufacturing, including ISO 13485:2003 medical device materials, related processes, and GMP (Good Manufacturing Practices).
  • · Utilize design development, analysis and statistical tools, to include Creo, Minitab, and statistical methods, including DOE, SPC, Measurement System Analysis, Variable Gage R&R, attribute agreement analysis, ANOVA, t-test, and regression analysis.
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