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6 дней назад

Sr. Engineering Program Director, Quality Strategy & Investigation Excellence

223 200 - 334 800$
Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
senior/director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Sr. Engineering Program Director, Quality Strategy & Investigation Excellence (Medical Devices/Quality Intelligence): Building and scaling investigation excellence, reliability engineering, root cause analysis, and advanced quality analytics capabilities across a global matrix with an accent on predictive quality management, CAPA effectiveness, and critical quality event resolution. Focus on establishing enterprise investigation standards, leading complex recalls and investigations, developing technical experts, and driving data-driven improvements in medical device product performance.

Location: Remote, United States; listed locations include Mounds View, Minnesota; North Haven, Connecticut; Boston, Massachusetts; and Lafayette, Colorado.

Salary: USD 223,200–334,800 annually.

Company

hirify.global develops healthcare technologies and medical devices, serving patients across more than 150 countries.

What you will do

  • Establish and lead a centralized Investigation Excellence Engineering capability.
  • Develop strategies and governance for root cause analysis, advanced quality analytics, reliability engineering, and structured problem solving.
  • Provide escalation support for critical investigations, major quality events, recalls, and CAPAs.
  • Build technical communities, career pathways, training capabilities, and expertise for Quality Reliability Engineers and investigation specialists.
  • Partner with Quality, Engineering, Manufacturing, R&D, Clinical, Regulatory, Supply Chain, Customer Experience, and Digital leaders to identify emerging signals and improve product performance.
  • Direct design and development activities for medical device products or software systems, including feasibility studies, technical quality and reliability systems, documentation, suppliers, consultants, and personnel development.

Requirements

  • Baccalaureate degree meeting the stated U.S. or equivalent international degree requirements and a minimum of 15 years of relevant experience with 10+ years of managerial experience; alternatively, an advanced degree with a minimum of 13 years of relevant experience and 10+ years of managerial experience.
  • Advanced management and leadership knowledge for leading cross-department project teams and multiple functions.
  • Mastery in a specific technical discipline or broad expertise across multiple related disciplines.
  • Ability to lead multiple strategic programs, influence senior and executive leadership, and manage large matrixed teams and vendors without direct reporting responsibility.
  • Roles below the Principal level require unrestricted U.S. work authorization at hire and throughout employment; sponsorship is limited to Principal-level roles and above.
  • For bachelor's degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

  • Advanced degree in Engineering, Reliability Engineering, Statistics, Applied Mathematics, Data Science, Materials Science, or a related discipline.
  • Experience in medical devices, aerospace, defense, semiconductor, automotive, energy, or another high-reliability industry.
  • Expertise in Shainin Red X, Fault Tree Analysis, Apollo RCA, Event & Causal Factor Analysis, Physics of Failure, reliability-centered investigations, and Six Sigma.
  • Experience leading Reliability Engineering, Failure Analysis, Investigation Excellence, or Quality Intelligence organizations.
  • Expertise in Weibull analysis, reliability growth, accelerated life testing, reliability modeling, DOE, regression modeling, predictive analytics, Bayesian methods, and complex data interpretation.
  • Experience deploying enterprise-wide technical training and certification programs and developing communities of practice or technical career frameworks.
  • Formal certifications in Reliability Engineering, Six Sigma, Shainin Red X, Quality Engineering, Statistics, or related disciplines.

Culture & Benefits

  • Remote workplace type within the United States.
  • Regular employees may receive health, dental, vision, life, disability, retirement, paid time off, paid holidays, tuition assistance, and employee stock purchase benefits, subject to eligibility.
  • The position is eligible for the hirify.global Incentive Plan short-term incentive.
  • Work is performed in a global, cross-functional, matrixed environment focused on patient outcomes, quality intelligence, and continuous improvement.

Hiring process

  • Applications must be submitted through official hirify.global channels.
  • The anticipated application window closes on 9 November 2026.

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