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Senior Manager, Product & Technology Development

Therakos

Salary not specified
Jul 31, 2025
Franklin, TN, US
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The company is looking for a Sr. Manager, Product & Technology Development to execute the company’s product, technology and innovation roadmap by managing a team of engineers focused on end-to-end product lifecycle management in the life sciences & technology space.

Requirements

  • 7+ years of experience in medical device product development, with at least 3 years in leadership roles.
  • Demonstrated success in developing & launching class II/III FDA-regulated medical devices as well as EU MDR environment.
  • Strong knowledge of design controls (ISO 13485), DHF, risk management, MDR regulation and usability engineering.
  • Excellent problem solving skills with hands-on execution capabilities.
  • PMP certification or significant experience in structured project management methodologies is highly desired.

Responsibilities

  • Lead, mentor, and develop a team of engineers to achieve technical and professional growth
  • Provide guidance for complex engineering challenges.
  • Plan, prioritize and manage engineering projects from concept to completion ensuring projects are delivered on time, within scope and budget.
  • May lead the development lifecycle of Class II/III medical devices, including concept, design, development, verification/validation, and transfer to manufacturing.
  • Oversee design control processes in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations.
  • Foster a culture of design excellence, design reliability/risk management, and continuous improvement.
  • Ensure effective design transfer and scale-up into manufacturing.

Other

  • Bachelor’s degree in engineering, (Mechanical, Electrical, Software, Biomedical Sciences, or a related field (MS/MBA a plus).
  • Experience managing global teams a plus.
  • Strong leadership, communication, and stakeholder management skills.
  • Drive performance through clear objectives, accountability, and professional development.
  • Partner and act as a liaison with other functions of the business including Regulatory Affairs, Quality Assurance, Marketing, and Operations to align development activities with business and compliance requirements.