Senior Product Development Manager

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 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 SolidWorks, Minitab or comparable engineering applications and project-management tools.

Why Join Hemanext?

At Hemanext, you'll have the opportunity to contribute to innovative medical technology while working in a collaborative environment where individual contributions can have meaningful visibility and impact.

Hemanext offers a comprehensive employee benefits and rewards package designed to support employees both professionally and personally, including:

• Competitive compensation
• Annual cash bonus opportunity based on applicable individual and company performance criteria
• Comprehensive health and welfare benefits, including medical, dental, and vision coverage
• Paid time off and company-paid holidays
• Employee assistance and wellness resources
• Rewards & Recognition Program, providing opportunities for employees to be recognized for meaningful contributions, exceptional performance, and demonstration of Hemanext's values
• Opportunities to work cross-functionally and contribute to the continued growth of an innovative medical device company