Job Description

Position Summary

We are seeking a results-driven Engineering Manager to lead and mentor a team of engineers in the design, development, and lifecycle management of medical devices. This individual will play a key role in driving innovation, ensuring regulatory compliance, and delivering products that meet user needs and quality standards.

The ideal candidate will have strong leadership skills, technical expertise in medical device development (Class I, II, or III), and a solid understanding of FDA, ISO, and other applicable standards.

Key Responsibilities

• Lead, mentor, and develop a multidisciplinary engineering team (mechanical, electrical, software, systems).
• Oversee the design, development, and testing of medical devices from concept through commercialization.
• Drive cross-functional collaboration with R&D, Quality, Regulatory Affairs, Manufacturing, and Marketing teams.
• Manage project timelines, budgets, resources, and risk mitigation strategies.
• Ensure design controls and documentation comply with FDA 21 CFR 820, ISO 13485, and other relevant standards.
• Participate in product architecture and system-level design decisions.
• Support verification and validation (V&V) planning and execution.
• Facilitate design reviews, technical assessments, and root cause analyses.
• Implement best practices for engineering processes, including design for manufacturability (DFM) and design for reliability (DFR).
• Stay current on industry trends, emerging technologies, and regulatory changes.

Required:

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field).
• 5+ years of experience in engineering, including 2+ years in a leadership or management role.
• Proven experience developing and commercializing medical devices.
• Strong knowledge of regulatory requirements (FDA, ISO 13485, IEC 60601, etc.).
• Excellent leadership, communication, and interpersonal skills.
• Demonstrated ability to lead technical teams and manage multiple projects.

Preferred:

• Master’s degree in Engineering, Business, or related field.
• Experience with Class II or III medical devices.
• PMP certification or formal project management training.
• Experience with product lifecycle management (PLM) tools and Agile development methodologies.

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