Senior Product Development Manager

Hemanext is seeking a Senior Product Development Manager to provide technical and organizational leadership across New Product Development (NPD) and Sustaining Engineering.

This highly visible role will help lead medical device development from early-stage concept and user needs through design, verification and validation, manufacturing transfer, commercialization, and ongoing product lifecycle management.

The Senior Product Development Manager will lead technical resources, drive complex engineering programs, identify and mitigate technical risks, and collaborate closely with Quality, Regulatory, Manufacturing, Clinical, Marketing, Sales, external partners, and senior leadership.

We're looking for an experienced medical device leader who combines strong technical judgment with the ability to develop people, manage competing priorities, and deliver results in a fast-paced, entrepreneurial environment.

What You'll Do

• Lead New Product Development and Sustaining Engineering activities in support of company and product priorities.
• Provide technical leadership throughout the medical device product lifecycle, from ideation and requirements development through design, verification/validation, manufacturing transfer, and commercialization.
• Lead and develop technical resources while helping build 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.

What You'll Bring

Required Qualifications

• Bachelor's degree in Mechanical, Biomedical, Materials/Plastics, Chemical Engineering, or a related engineering discipline.
• 7+ years of experience in medical device product development.
• 5+ years of experience leading technical teams and/or managing medical device product-development programs.
• Demonstrated experience supporting medical devices through the product lifecycle, including design, verification/validation, manufacturing transfer, and commercialization.
• Experience working within an ISO 13485-compliant Quality Management System and applicable FDA medical-device requirements.
• Experience with design controls, technical risk management, design reviews, and Design History File documentation.
• Demonstrated ability to manage complex technical programs while balancing quality, performance, schedule, resources, and budget.
• Strong technical, leadership, communication, and cross-functional collaboration skills.
• Ability to prioritize and execute across multiple initiatives in a fast-paced environment.

Preferred Qualifications

• Advanced engineering degree.
• Experience in blood transfusion, blood collection, or separation technologies.
• Experience with design verification and validation, process validation, and clinical validation studies.
• Experience with Solid Works, Minitab or comparable engineering applications and project-management…