Engineering Manager

We are seeking a results-driven Engineering Manager to lead a multidisciplinary team in the design, development, and manufacturing of innovative medical devices. This role is critical to ensuring engineering excellence, regulatory compliance, and cross-functional collaboration throughout the product lifecycle.

Key Responsibilities

• Lead and mentor a team of engineers across mechanical, electrical, and manufacturing disciplines.
• Oversee design control activities in accordance with FDA, ISO 13485, and other applicable standards.
• Drive execution of product development projects from concept through commercialization.
• Collaborate with Quality, Regulatory, Operations, and Marketing to ensure successful product launches.
• Manage engineering resources, budgets, and timelines to meet business objectives.
• Support continuous improvement initiatives using Lean, Six Sigma, and other methodologies.
• Ensure robust documentation including DHF, DMR, and risk management files.
• Evaluate and implement new technologies, tools, and processes to enhance product performance and manufacturability.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, or related field); Master's preferred.
• 7+ years of experience in medical device engineering, with at least 2 years in a leadership role.
• Strong understanding of design controls, validation (IQ/OQ/PQ), and regulatory requirements.
• Proven track record of leading cross-functional teams and delivering complex projects.
• Excellent communication, organizational, and problem-solving skills.

Preferred Skills

• Experience with Class II or III medical devices.
• Familiarity with CAD tools, ERP systems, and PLM platforms.
• Certified Six Sigma Green or Black Belt.
• PMP or similar project management certification.

What We Offer

• Competitive compensation and benefits package.
• Opportunity to work on life-changing technologies.
• Collaborative and mission-driven culture.
• Professional development and growth opportunities.