Hybrid Senior Hardware Engineering Manager at MGC Diagnostics

We are seeking a results-driven Senior Hardware Engineering Manager to lead and grow our multidisciplinary hardware team. This individual will oversee the development and support of electromechanical medical devices, guiding both new product development (NPD) and sustaining engineering activities. 

The ideal candidate is a hands-on leader with strong technical acumen, team-building capabilities, and a proven track record of delivering compliant and innovative solutions in a regulated environment.

Essential Functions 

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Lead and manage a growing cross-functional hardware team.
• Provide clear direction, assign tasks, set priorities, and conduct performance reviews to support professional development and team growth.
• Mentor junior engineers and technicians, fostering technical excellence and career development.
• Own end-to-end mechanical and hardware project execution, including concept development, design, prototyping, verification, validation, and transfer to manufacturing.
• Drive both new product development and sustaining engineering efforts across a range of electromechanical systems.
• Review and approve engineering designs, tolerance analysis, test plans, and design documentation in accordance with medical device requirements.
• Provide technical leadership in the design and integration of mechanical, electrical, and pneumatic systems, including collaboration with software, firmware, and electrical teams.
• Oversee prototyping, benchtop testing, and design verification and validation activities.
• Ensure compliance with applicable regulations and standards, including FDA 21 CFR 820, ISO 13485, ISO 14971, and IEC 60601-1.
• Collaborate cross-functionally with product management, manufacturing, quality, regulatory, and supply chain to ensure design feasibility, manufacturability, and scalability.
• Communicate program status, risks, and mitigation strategies to leadership and stakeholders.
• Establish and implement engineering best practices, procedures, and design standards.
• Identify and lead opportunities for process improvement, cost reduction, and design optimization.

Competencies/Success Factors 

• Project/ Task Management
• Mechanical Skills
• Results Focus/ Output Orientation
• Creativity/ Innovation
• Team Orientation
• Interpersonal Communication
• Coaching/ Developing Others
• Leadership

Supervisory Responsibility 

Supervises Mechanical Engineering and Sustaining/ Manufacturing Engineering Teams.

Work Environment 

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones and photocopiers.

Periodic time on the production floor is expected.

Physical Demands