12 days old

Released Product Engineer I

Mounds View, MN 55112
  • Job Code
Careers that Change Lives

A Day in the Life

  • Contribute to the continuous improvement and support of existing production heart valve repair and replacement devices.
  • Develop and implement test methods and equipment to conduct tests on materials, components, and devices to meet development and regulatory requirements.
  • Conduct verification testing per approved protocols and document in accordance with applicable development regulatory requirements.
  • Collaborate with design colleagues to ensure designs are capable of meeting performance targets.
  • Document design in accordance with applicable Released Product Development Protocol, Quality and Regulatory requirements.
  • Prepare regulatory submission-ready documentation for the FDA and other regulatory bodies.
  • Support multiple projects within the Released Product Engineering group

    Responsibilities Include:

  • Support sustaining engineering programs for existing products to ensure sustainable and stable operations of production. Identify areas that require additional investigation
  • Provide solutions to a variety of technical problems of limited scope and complexity.
  • Contribute to design, development, research and support of existing production heart valve products for medical utilizing systematic engineering methods, physical/computational modeling, and data analysis.
  • Document design solutions and design modifications in accordance with internal Medtronic, industry and regulatory requirements.
  • Support verification and validation testing and perform analysis to evaluate designs for short and long-term performance and reliability.
  • Support design of test fixtures, measurement techniques, and equipment consistent with drafting standards and in accordance with ASTM and regulatory requirements.
  • Collaborate with other Design, Research, Manufacturing and Quality colleagues to ensure designs are capable of being manufactured consistently and cost effectively.
  • Compile and analyze data and define changes required in design concepts, testing equipment, testing procedures or new testing requirements.
  • Maintain technical knowledge current with advancing technology related to cardiovascular valve repair/replacement products and associated accessories by engaging in continuing education programs in selected disciplines and in new fields of engineering and/or project management.
  • Work under general supervision. Follow established procedures.
  • Review and approve document change orders for design, materials, and process documentation.
  • Interact professionally with immediate supervisor, project leaders, and other professionals in the section or group. Occasionally interact with inter-organizational contacts. Comply with applicable corporate and departmental policies.
  • Perform required training and certifications to demonstrate compliance with applicable divisional and corporate policies in accordance with individual training matrix.

      Must Have:
    • Bachelor's Degree with 0+ years of experience required

      Nice to Have:

    • BS or MS in Mechanical Engineering, Biomedical Engineering, or Materials Science
    • Experience in relevant development engineering or research
    • PC experience (MS Word, Excel, PowerPoint, MS Project, Outlook, etc.).
    • Familiar with basic lab equipment.
    • A good communicator and fluent in English, both in writing and speaking.
    • Working knowledge of risk management analysis including Failure Mode and Effects Analysis (FMEA)
    • Good Manufacturing Practices (GMP)/Quality System Regulations (QSR).
    • Knowledge of FDA, MDD, and CMDR
    • Experience with GMP, ISO 13485:2005, and QSR 21 CFR part 820
    • Knowledge of human anatomy and physiology.
    • Knowledge and experience in engineering mechanics, mechanical design, and structure and properties of materials.
    • Experience with CAD software such as SolidWorks.
    • Hands on experience with laboratory testing methods and fluid flow measurements.
    • A dynamic team player who can work effectively and proactively on cross-functional teams.
    • Experience with Design Verification, Design Validation and design control (e.g., Product Development Protocol, Design History Files and Device Master Record)

      Physical Requirements:

    • While performing the duties of this job, the employee is regularly required to be independently mobile.
    • The employee is also required to interact with a computer and communicate with peers and co-workers.
    • May need to sit at a computer terminal for extended periods of time
    • Employee must occasionally lift and move up to 30 lbs
    • May require domestic and international travel, up to 10% of the time
    • Physical capabilities to perform the job
    • Use a microscope, perform fine close work up to 8 hours/day
    • May be required to wear eye protection to accommodate laser use
      About Medtronic
      Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

      We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

      Physical Job Requirements
      The physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

    Additional Information

    • Posting Date: Jan 4, 2021
    • Travel: No

  • Posted: 2021-01-06 Expires: 2021-02-04
    Sponsored by:
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    Sponsored by:
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