Senior Hardware Engineering Manager

Job Description

Job Description

Summary / Objective

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

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

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.

Occasional lifting up to 50 lbs., occasional heavier lifting.

Occasional pushing, pulling and handling of materials.

Travel

Very limited travel.

Required Education and Experience

Bachelor’s degree in Mechanical Engineering or closely related field.

7+ years of mechanical engineering experience with progressive responsibilities.

2–4 years of people leadership or technical management experience.

Proficiency with CAD tools such as SolidWorks or AutoCAD.

Strong understanding of materials, mechanical components, and manufacturing processes including injection molding, machining, and pneumatic systems.

Experience working in a regulated medical device environment.

Familiarity with ISO 14971, IEC 60601-1, and FDA design controls (21 CFR 820).

Strong project management, problem-solving, and communication skills.

Demonstrated ability to lead cross-functional collaboration and deliver products on schedule and within budget.

Preferred Education and Experience

Master’s degree in Mechanical Engineering, Systems Engineering, or related discipline.

Experience managing teams across multiple engineering disciplines (e.g., mechanical, electrical, manufacturing).

Exposure to product lifecycle management (PLM) tools and formal change control systems.

Experience scaling engineering teams and processes in a fast-growing environment.

Familiarity with FEA, tolerance stack-ups, and root cause analysis tools (e.g., FMEA, 8D).

Additional Eligibility Qualifications

None required for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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.