The Role
Leads a cross-functional team of up to 10 engineers executing the product and technology innovation roadmap for therapeutic apheresis and cell therapy devices. Oversees Class II/III medical device development from concept through commercialization, including design controls, verification and validation, regulatory compliance, risk management, design transfer, and manufacturing scale-up. Partners with Regulatory Affairs, Quality Assurance, Marketing, and Operations while driving innovation, intellectual property generation, project delivery, and team development.
Summary Generated by Built In
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.
Job requirements
Education:
Job responsibilities
Benefits
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.
Job requirements
Education:
- Bachelor’s degree in engineering, (Mechanical, Electrical, Software, Biomedical Sciences, or a related field (MS/MBA a plus).
- 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.
- 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.
Job responsibilities
- 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.
Benefits
- 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.
Skills Required
- Bachelor's degree in engineering, biomedical sciences, or a related field
- 7+ years of experience in medical device product development
- At least 3 years of experience in leadership roles
- Experience developing and launching Class II/III FDA-regulated medical devices
- Experience working in the EU MDR environment
- Knowledge of design controls, ISO 13485, Design History Files, risk management, MDR regulations, and usability engineering
- Strong leadership, communication, stakeholder management, problem-solving, and execution skills
- PMP certification or significant experience with structured project management methodologies
- MS or MBA degree
- Experience managing global teams
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The Company
What We Do
Therakos provides the THERAKOS® CELLEX® Photopheresis System for the palliative treatment of skin manifestations of Cutaneous T-Cell Lymphoma (CTCL) that is unresponsive to other forms of treatment.
