Senior Manager, Product & Technology Development
Therakos Nashville, Tennessee, United States
Pharmaceutical Manufacturing · 51-200 employees
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About the role
The Senior Manager will lead a cross-functional R&D team to execute product innovation roadmaps from concept through commercialization. They are responsible for overseeing design controls, ensuring regulatory compliance, and fostering a culture of design excellence and continuous improvement.
What they look for
Requirements
Candidates must hold a bachelor's degree in an engineering or biomedical field and possess at least 7 years of experience in medical device development. Proven leadership in FDA-regulated environments and expertise in design controls and risk management are essential.
Benefits
Full description
The Sr. Manager, Product & Technology Development is a senior leader within the R&D organization responsible for executing the company’s product, technology and innovation roadmap. This role will directly manage a cross-functional team of up to 10 engineers (spanning mechanical, electrical, software, and biomedical disciplines) focused on end-to-end product lifecycle management. From concept through commercialization, this leader will drive advancements specifically within therapeutic apheresis and cell therapy technology space. The ideal candidate combines project & team leadership, execution focus, engineering discipline and a passion for innovation. Education:• Bachelor’s degree in engineering, (Mechanical, Electrical, Software, Biomedical Sciences, or a related field (MS/MBA a plus).
Experience:
- 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.
- Experience managing global teams a plus.
Skills & Competencies:
- Strong knowledge of design controls (ISO 13485), DHF, risk management, MDR regulation and usability engineering.
- Strong leadership, communication, and stakeholder management skills.
- Excellent problem solving skills with hands-on execution capabilities.
- PMP certification or significant experience in structured project management methodologies is highly desired.
- Lead, mentor, and develop a cross-functional team of up to 10 engineers to execute the product innovation roadmap,
- Provide guidance for complex engineering challenges across mechanical, electrical, software, and biomedical domains.
- Plan, prioritize and manage engineering projects from concept to completion, utilizing tools like Smartsheet to ensuring projects are delivered on time, within scope and budget.
- 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.
- Drive performance through clear objectives, accountability, and professional development.
- Drive intellectual property generation and contribute to a strong, defensible patent portfolio.
- 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.
- Ensure effective design transfer and scale-up into manufacturing.
- Monitor emerging technologies, market trends, and competitive landscape to identify innovation opportunities.
- Competitive salary and benefits package
- Opportunities for professional development and career growth.
- Collaborative and innovative work environment.
Disclaimer: The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
