Product Design Manager Jobs in Burlington, MA

Job Summary: We are seeking a Senior Mechanical Engineer to provide technical leadership and hands-on expertise in the development of mechanical circulatory support devices. This role focuses on the design, analysis, prototyping, testing, and commercialization of complex electromechanical and implantable medical devices. The ideal candidate will have strong experience in product development, mechanical testing, and regulated medical device environments.

Key Responsibilities:

• Design, develop, verify, and validate mechanical components and subsystems for advanced medical devices.
• Apply analytical and experimental methods, including finite element analysis and computational modeling, to optimize product performance and reliability.
• Develop and execute test methods, protocols, and simulation models to evaluate product robustness and mitigate design risks.
• Create and maintain engineering documentation including CAD models, drawings, specifications, and technical reports.
• Lead design reviews, risk assessments, and cross-functional technical discussions.
• Collaborate with systems, electrical, software, clinical, quality, and manufacturing teams throughout the product lifecycle.
• Support prototype development, component sourcing, and supplier interactions.
• Mentor junior engineers and contribute to engineering best practices and continuous improvement initiatives.

Required Qualifications:

• Bachelor’s degree in Mechanical Engineering or a related STEM discipline.
• Minimum 6 years of experience in mechanical design and product development.
• Experience within the medical device industry.
• Proficiency with SolidWorks or equivalent CAD software.
• Experience with geometric dimensioning and tolerancing (GD&T).
• Experience developing and executing mechanical test methods using Instron or similar tensile/compression testing systems.
• Knowledge of finite element analysis tools and engineering simulation techniques.
• Strong understanding of materials, manufacturing processes, and design for reliability.
• Experience leading technical projects in regulated environments.
• Strong written and verbal communication skills.

Preferred Qualifications:

• Experience with Class III implantable medical devices.
• Experience with cardiovascular technologies or mechanical circulatory support devices.
• Knowledge of design controls and regulated product development processes.
• Familiarity with ISO 13485, ISO 14971, and applicable regulatory requirements.
• Experience with computational modeling, fluid dynamics, or hemocompatibility testing.
• Experience with electromechanical integration and biocompatible materials.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.

Pay Range: $55/hr to $65/hr