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Project Manager – Medical

Project Manager – Medical

CompanyEssity
LocationManchester, CT, USA
Salary$80000 – $120000
TypeFull-Time
DegreesBachelor’s
Experience LevelSenior

Requirements

  • Bachelor of Science in Engineering or related technical discipline.
  • 5+ years of relevant experience in process development and/or manufacturing engineering.
  • PMP Certification highly desirable.

Responsibilities

  • Utilize best-practice Project Management, organizational, and communication skills in the day-to-day management of assigned projects as a project lead, or as a project support team member, throughout the lifecycle of a project; from project idea (start) to lessons learned (finish).
  • Manage Key Performance Indicators (KPIs): project budgets (cost), project plan (time), project deliverables (quality), and project team (resources) to deliver projects on time, in full.
  • Provide site-wide PMO improvements to people, processes, and products; aligned to the global PMO function.
  • Analyze current processes to identify improvement opportunities.
  • Align all investment and development projects with corporate financial systems for transparency, and status, generating and executing detailed project plans to achieve project success criteria.
  • Align site operational activities with Sales & Marketing teams (regional and global).
  • Identify and negotiate with external suppliers and equipment firms to explore manufacturing capabilities best to achieve site performance objectives.
  • Direct the installation and validation of novel manufacturing methods in compliance with medical device quality standards including ISO 13485. Provide engineering support to Quality related to Non-Conforming Product and CAPA investigations.
  • Provide engineering support related to risk analysis tools including FMEA’s.
  • Validate activities associated with manufacturing equipment and processes including packaging and sterilization.
  • Collaborate with manufacturing team including quality, finance, and section leaders.

Preferred Qualifications

  • Experience working in a regulated industry such as ISO 9001, AS9100, ISO 13485 with a strong mechanical/electrical aptitude preferred.
  • Knowledge of automated and semi-automated manufacturing equipment preferred.
  • Knowledge of statistical process control preferred.