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.
