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Sr Software Quality Engr

Lafayette, CO 80026

Posted: 05/08/2024 Employment Type: Contract Job Category: Engineering Job Number: 606302 Is job remote?: No Country: United States

Job Description

Pay 50-60/h depending on experience

Top 3 technical  skills that are required for the role:

  1.  Risk management: experience in assessing and mitigating risks associated with SW development in medical devices following ISO 14971.
  2. Software development life cycle (SDLC): experience in SDLC for medical device, or highly regulated industry.
  3. SW verification and validation: experience in testing methodologies.

Education Required: Minimum: BS in technical areas.

Years’ Experience Required: minimum: 7 years.

Responsibilities may include the following and other duties may be assigned:
  • Develop, modify, apply, and maintain standards for software systems quality operating methods, processes, and procedures
  • Define appropriate measures to ensure software quality
  • Actively participate in new product development lifecycle by engaging with cross-functional partners in early development phases on design concepts, development strategies, risk management, and verification and validation test approaches
  • Support Software New Product Development, Design Control, and Design Transfer processes, as well as responsibility for Quality deliverables during product development
  • Lead risk management activities and participate on cross-functional teams to develop and maintain Product Risk Management Files
  • Identify and implement software process metrics for the software product development lifecycle
  • Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives
  • Follow all Quality System Practices as defined by Medtronic Navigation’s practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable

Requires a University Degree and minimum of 6 years of relevant experience, or advanced degree with a minimum of 4 years relevant experience.

Must Have
  • Agile Software Development practices
  • Bachelor’s Degree in Engineering, Science or technical field with 5+ years of work experience in Engineering and/or Quality OR Master’s Degree Engineering, Science or technical field with 3+ years of work experience in Engineering and/or Quality.
  • Expertise in CAPA compliance & investigation techniques.
  • Auditing experience to 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR, the Medical Device Directive and MDSAP. Training in Risk Management, ISO 14971:2012, hazard analysis, and Design FMEA.
  • Must work well in cross-functional teams and be a self-starter.
  • Excellent written and verbal communication skills.
  • Excellent organizational skills.
  • Computer literacy must include proficiency with MS Office and experience with networks and applications.

Nice To Have
  • 5+ years of experience supporting new product development activities in medical device
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