Senior Medical Device Product Development Lead

Hemanext; Lexington (MA); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Competitive compensation

Annual cash bonus

Medical, dental, and vision coverage

Paid time off and holidays

Employee assistance program

Rewards & Recognition Program

Cross-functional collaboration

Job summary

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 guide medical device development from concept and user needs through design, verification and validation, manufacturing transfer, commercialization, and lifecycle management.

You will lead technical resources, drive complex programs, identify and mitigate risks, and collaborate with Quality,

Qualifications

• Bachelor's degree in an engineering discipline and 7+ years in medical device product development.
• 5+ years leading technical teams and/or managing development programs.
• Experience with ISO 13485 QA systems, FDA medical-device requirements, design controls, risk management, and Design History File documentation.

Responsibilities

• Lead NPD and Sustaining Engineering activities aligned with company priorities.
• Provide technical leadership across product lifecycle from ideation to commercialization.
• Develop and mentor resources, build a high-performing engineering organization.
• Drive program planning, risk management, troubleshooting, and issue resolution.
• Serve on cross-functional core teams to ensure user needs, quality, manufacturability, schedule and budget.
• Translate market needs into robust, manufacturable product solutions with Marketing and Sales.
• Communicate scope, risks, and tradeoffs to stakeholders and senior leadership.
• Ensure compliance with QMS, design controls, and regulatory requirements.
• Support design reviews, DHF documentation, and technical records.
• Build relationships with external partners to supplement internal capacity.

Skills

Strong technical leadership

Cross-functional collaboration

Project management

Design controls

Quality/regulatory understanding

Communication

Prioritize multiple initiatives

Team leadership

Education

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

Advanced engineering degree

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 guide medical device development from concept and user needs through design, verification and validation, manufacturing transfer, commercialization, and lifecycle management.

You will lead technical resources, drive complex programs, identify and mitigate risks, and collaborate with Quality,