M

Medtronic

Medical device maker advancing therapies

Engineering Program Manager/QCTM - Ent

Program ManagementUpdated on Nov 13
Full-timeJacksonville, FL, USA

About the Job

Requirements

  • A bachelor's degree with at least five years of technical experience in an engineering, quality, technical, or program management environment, or a master's degree with at least three years of such experience.
  • Experience leading cross-functional product development or quality programs.
  • Experience applying risk management, quality, and reliability methodologies in regulated product development environments.
  • Experience with quality systems, design controls, and product lifecycle management processes.
  • Experience supporting compliance with regulated industry requirements and standards.
  • For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

  • Lead quality and reliability strategy, plans, metrics, and risk management activities for assigned new product development programs.
  • Manage execution across extended quality functions, including design quality, software quality, supplier quality, manufacturing quality, and reliability engineering teams.
  • Represent the Voice of Quality on cross-functional core teams and serve as the final quality authority for assigned projects.
  • Drive Design Reliability and Manufacturability, Design for Reliability, First Time Quality, and defect prevention initiatives throughout product development.
  • Identify quality and reliability risks, implement risk reduction strategies, and lead root cause investigations and corrective and preventive actions.
  • Partner with suppliers and manufacturing sites to evaluate quality risks, support sourcing decisions, and ensure readiness for product launch and lifecycle management.
  • Lead compliance planning, assessments, audit support activities, and adherence to quality system and regulatory requirements.
  • Support key development deliverables, including Design History Files, Device Master Records, Production Part Approval Process, regulatory submissions, software lifecycle documentation, and product transfer activities.

Desired Qualifications

  • Project Management Professional certification.
  • Design Reliability and Manufacturability certification or equivalent experience.
  • First Time Quality certification.
  • Experience with medical device product development and software development lifecycle processes.
  • Knowledge of FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62304 requirements.

About the Company

Medtronic

Medical device maker advancing therapies

Medtronic develops medical devices that diagnose, monitor, and treat chronic diseases. Its products include implantables, sensors, and therapies used in cardiovascular care, diabetes management, and neurostimulation, working by interacting with the body to regulate or monitor physiological processes. The company differentiates itself through a long history of device development, strategic acquisitions like Covidien, and a broad, diversified portfolio across therapeutic areas. Its goal is to improve patients’ health outcomes by delivering integrated medical technologies and solutions for disease management.

Company size
10,001+
Company stage
IPO
Headquarters
Fridley, MN
Founded
1949

Recently Posted Jobs

Explore more opportunities at Medtronic

See more jobs