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About the Role
This senior leadership role within R&D is responsible for executing the company’s product, technology, and innovation roadmap. You will manage a cross-functional team of engineers, driving end-to-end product lifecycle management in therapeutic apheresis and cell therapy technology. The ideal candidate possesses strong project and team leadership, execution focus, engineering discipline, and a passion for innovation.
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.
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.
- Experience managing global teams a plus.
Skills
- 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.
Experience Level
- Senior level
- 3+ years in leadership roles
Education Level
- Bachelor’s degree in engineering, (Mechanical, Electrical, Software, Biomedical Sciences, or a related field (MS/MBA a plus).
Benefits
- Competitive salary and benefits package
- Opportunities for professional development and career growth.
- Collaborative and innovative work environment.