Senior Medical Device Product Lead

Hemanext, Inc.; Lexington (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Hemanext is seeking a Senior Product Development Manager to provide technical and organizational leadership across NPD and Sustaining Engineering. You will guide medical device development from concept through validation, manufacturing transfer, and lifecycle management, driving risk mitigation and cross-functional collaboration.

You’ll lead a high‑performing team, partner with Quality, Regulatory, Manufacturing, Clinical, Marketing, and Sales, and ensure design controls and QMS compliance in a

Qualifications

• Bachelor's degree in an engineering discipline.
• 7+ years in medical device product development.
• 5+ years leading technical teams or programs.
• Experience with ISO 13485 and FDA medical-device requirements.
• Design controls and Design History File experience.
• Ability to manage complex programs balancing quality, performance, schedule, resources, and budget.

Responsibilities

• Lead New Product Development and Sustaining Engineering activities.
• Provide technical leadership throughout the product lifecycle, from ideation through design, verification/validation, manufacturing transfer, and commercialization.
• Lead and develop technical resources while building a collaborative, high-performing engineering organization.
• Drive technical planning, execution, risk identification, mitigation, troubleshooting, and resolution across product-development programs.
• Serve as a Product Development member of cross-functional core teams, ensuring products meet user needs, product requirements, quality standards, manufacturability, schedule, and budget expectations.
• Translate customer and market needs into technically robust, manufacturable product solutions in partnership with Marketing, Clinical, and Sales.
• Communicate technical scope, risks, tradeoffs, and recommendations effectively to cross-functional stakeholders and senior leadership.
• Ensure Product Development activities comply with Hemanext's QMS, design-control procedures, and applicable regulatory requirements.
• Support development plans, design and phase reviews, Design History File documentation, and other required technical records.
• Build and maintain relationships with external technical partners and resources to supplement internal expertise and capacity when needed.

Skills

Strong technical leadership

Cross-functional collaboration

Excellent communication

Prioritization across initiatives

Education

Bachelor's degree in Mechanical, Biomedical, Materials/Plastics, Chemical Engineering

Tools

SolidWorks

Minitab

Job description

Hemanext is seeking a Senior Product Development Manager to provide technical and organizational leadership across NPD and Sustaining Engineering. You will guide medical device development from concept through validation, manufacturing transfer, and lifecycle management, driving risk mitigation and cross-functional collaboration.

You’ll lead a high‑performing team, partner with Quality, Regulatory, Manufacturing, Clinical, Marketing, and Sales, and ensure design controls and QMS compliance in a