Senior Software Safety Engineer - Crm

Medtronic UK

Mounds View, MN, United States
Base: $106,400.00 - $159,600.00; bonus/equity: med...
Patient safety hazards identification
Risk management files maintenance
Iso 13485, iso 14971, iec 62304 compliance
You will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business

Job Summary

  • You will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.
  • Collaborates with cross-functional teams to develop and release new cardiac rhythm management software products and design changes.
  • Medtronic offers a competitive Salary and flexible Benefits Package.

Matching Summary

You will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.

Salary

Base: $106,400.00 - $159,600.00; Bonus/Equity: Medtronic Incentive Plan (MIP); Benefits: Health, Dental and vision insurance, HSA, FSA, Life insurance, Long-term disability, Dependent daycare spending account, Tuition assistance/reimbursement, Simple Steps, 401(k) with match, Paid time off, Paid holidays, ESPP, EAP, Non-qualified Retirement Plan Supplement, Capital Accumulation Plan

Skills & Requirements

Must-have

  • patient safety hazards identification
  • risk management files maintenance
  • ISO 13485, ISO 14971, IEC 62304 compliance
  • design validation and verification
  • risk mitigation recommendations
  • data-driven risk-benefit analyses

Nice-to-have

  • fostering a culture of professional growth
  • cross-functional collaboration
  • innovative risk mitigations
  • artificial intelligence (AI) tools knowledge
  • Design for Six Sigma (DFSS)

Key Requirements

  • Bachelor’s degree in engineering, math, science or technical discipline and minimum of 4+ years of work experience in engineering and/or quality OR advanced degree in engineering, science or technical field with 2+ years of work experience in engineering and/or quality.
  • Proven understanding of product reliability/safety engineering principles.
  • Experience in a highly regulated industry, preferably implantable medical devices.
  • Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
  • Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HAL, FTA, DFMEA).
  • Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
  • Experience in design, maintenance, or continuation engineering of released software or software systems, including mobile applications.
  • Proficiency in two or more of the following technologies: C++, Java, JavaScript, HTML, C#, .NET, Python, Angular, Xamarin.

Work Rights

Unrestricted US work authorization required for roles below Principal level

Sponsorship: available

Tailored Resume

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