MGC Diagnostics
Senior Hardware Engineering Manager
MGC Diagnostics, Minneapolis, Minnesota, United States, 55400
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 Project/Task Management
Mechanical Skills
Results Focus/Output Orientation
Team Orientation
Interpersonal Communication
Coaching/Developing Others
Leadership
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 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. 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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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 Project/Task Management
Mechanical Skills
Results Focus/Output Orientation
Team Orientation
Interpersonal Communication
Coaching/Developing Others
Leadership
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 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. 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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