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Full-Time

Systems Engineer

Confirmed live in the last 24 hours

Medtronic

Medtronic

5,001-10,000 employees

Develops and manufactures medical devices and therapies

Healthcare
Biotechnology

Compensation Overview

$96.3k - $124.8kAnnually

Junior, Mid

Boston, MA, USA + 1 more

More locations: Boxborough, MA, USA

Hybrid model requiring onsite presence in Boxborough, MA for 3-4 days per week.

Category
Design Engineering
Manufacturing Engineering
Mechanical Engineering
Requirements
  • Masters’ Degree in Mechanical, Industrial, or Biomedical Engineering, Bioengineering or related engineering field
  • one (1) year of experience as a systems engineer, R&D engineer, Biomedical engineer or related occupation in medical device product development
  • Must possess a minimum of one (1) year of experience with each of the following: DMAIC or DRM methodology, and Six Sigma
  • ISO 13485, ISO 14971, and IEC 60601-1
  • User interviews, development of user needs and generation of design criteria
  • Requirement Flow-down process and requirement traceability
  • Manufacturing process development and EQ/IQ
  • DOE, Ranging Studies, ANOVA, and regression analysis
  • 5 Why’s & Ishikawa (Fishbone)
  • Addressing Non-conformances in design process, investigating root-cause, and disposition plan.
Responsibilities
  • Develop and evaluate designs which meet defined product requirements and that are optimized for manufacturability, reliability, and overall cost to the business
  • Utilize DMAIC (Define, Measure, Analyze, Improve, and Control) or DRM (Design, Reliability, and Manufacturability) methodology and Six Sigma to suggest design or manufacturing process improvement
  • Navigate the complexity of industry regulations to include ISO 13485:2003, ISO 14971:2007 and IEC 60601-1
  • Coordinate risk activities to contribute in medical device development, related processes, and GMP (Good Manufacturing Practices)
  • Responsible for user interviews, development of user needs and generation of design criteria
  • Coordinate requirement flow-down process and requirement traceability utilizing requirement tool such as Cognition Cockpit (or similar system) and develop the templates for flow-down
  • Provide expertise in manufacturing process development, Equipment Qualification/ Installation Qualification (EQ/IQ) and provide relevant training
  • Utilize statistical tools, including Minitab
  • Evaluate medical product/process using techniques such as DOE (Design of Experiment), Ranging Studies, ANOVA, regression analysis, QMS (Quality Management System), and FDA 21 CFR Part 820
  • Troubleshoot manufacturing or other product-related issues utilizing problem solving techniques, including 5 Why’s and Ishikawa (Fishbone)
  • Address non-conformances in the manufacturing process, investigate root-cause, and disposition plan.

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals and healthcare professionals around the world. Medtronic stands out from competitors by not only focusing on product development but also offering comprehensive services such as training for healthcare providers and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through their advanced medical solutions.

Company Stage

IPO

Total Funding

$3.2M

Headquarters

Fridley, Minnesota

Founded

N/A

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • Medtronic's recent product innovations, such as the InterStim Micro Neurostimulator and remote monitoring systems, highlight its commitment to advancing medical technology.
  • The company's expansion in Asia, including the launch of the Robotics Experience Studio, indicates strong growth potential in emerging markets.
  • Strategic partnerships and acquisitions, like the collaboration with Ramsay Health Care and the acquisition of Paceart Optima, enhance Medtronic's capabilities and market position.

What critics are saying

  • The highly competitive medical technology market requires Medtronic to continuously innovate to maintain its leadership position.
  • Integration challenges from acquisitions and partnerships could potentially disrupt operations and delay product development.

What makes Medtronic unique

  • Medtronic's extensive R&D investment enables continuous innovation in medical technology, setting it apart from competitors who may not have the same level of resources.
  • The company's global reach, operating in over 150 countries, provides a significant advantage in market penetration and customer base.
  • Medtronic's comprehensive suite of products and services, including training and patient management programs, offers a holistic approach to healthcare that many competitors lack.