Senior Engineering Manager, Advanced Manufacturing (R&D)

Cordis-posted 2 months ago
Senior
Miami Lakes, FL
1,001-5,000 employees
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Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

  • Hiring a team of approximately 5 Engineering Teammates
  • Establishes operational objectives, policies, procedures and work plans and delegates assignments to experienced level and professional teammates.
  • Develops, modifies and executes company policies that affect immediate operations and may also have company-wide effect.
  • Oversees execution of transfer and installation of testing equipment, coating equipment, and packaging equipment
  • Oversees equipment qualification, test method validation, process validation, design validation testing, and bridging stability studies
  • Accountable for developing and adhering to R&D and Operations transfer budgets.
  • Works on issues where analysis of situations or data requires conceptual thinking and an in-depth knowledge of organizational objectives.
  • Drives the strategic direction and success of product transfers
  • Lead the engineering or technical leads with the purpose of completion of projects and the development of the pipeline of engineers and technical leads.
  • Develop and manage department goals and drive completion of the goals.
  • Collaborate with R&D, manufacturing, quality, and supply chain teams to ensure alignment and successful product launches.
  • Identify and mitigate risks associated with new product introductions.
  • Monitor and report on engineering or project technical progress and progress towards achieving Cordis goals.
  • Drive continuous improvement initiatives to enhance product quality, reduce costs, and improve time-to-market.
  • Ensure compliance with regulatory requirements and industry standards.
  • This role will have direct reports up to Principal level engineers
  • Bachelor’s degree in engineering
  • 10+ years of experience in Leading Engineering Teams, with a focus on new product design transfer and commercialization
  • PMA Experience
  • Medical device product development and operations experience
  • Strong leadership and project or functional management skills
  • Excellent communication and interpersonal skills
  • Proven ability to manage complex projects and cross-functional teams
  • Strong analytical and problem-solving skills
  • Experience in combination medical devices a plus
  • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
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