Senior Hardware Engineering Manager

Senior Hardware Engineering Manager – MGC Diagnostics

The following description includes responsibilities, qualifications, and expectations for the role of Senior Hardware Engineering Manager. This summary reflects the information provided in the source job description.

Summary

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

• 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

Supervisory Responsibility

Supervises Mechanical Engineering and Sustaining / Manufacturing Engineering Teams.

Work Environment and Physical Demands

This job operates in a professional office environment and periodically on the production floor. Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling may be required. Occasional lifting up to 50 lbs., occasional heavier lifting. Occasional pushing, pulling and handling of materials.

Travel

Very limited travel.

Required Education and Experience

Preferred Education and Experience

Additional Eligibility Qualifications

None required for this position.

Note : This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities. Duties, responsibilities, and activities may change at any time with or without notice.

Equal Employment Opportunity

MGC Diagnostics is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

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