Director of Hardware Engineering

Confidential Careers; Minneapolis, Saint Paul (MN, MN); On-site; USD 180,000 - 240,000; Full time

Job summary

Confidential Careers seeks a seasoned Hardware Engineering Director to lead electrical, embedded, mechanical, and electromechanical systems for medical devices. This leader will drive design, verification, validation, and transfer to manufacturing while ensuring compliance with stringent regulatory standards.

You will align cross-functional teams, coach talent, and establish best practices to improve execution, quality, and cost performance across programs.

Qualifications

• Bachelor’s degree in Electrical, Mechanical, Biomedical, or Systems Engineering.
• 12+ years of progressive engineering experience including hardware product development.
• 5+ years of engineering leadership including hiring, coaching, and org development.
• Proven ability to lead multidisciplinary teams through full product lifecycle.

Responsibilities

• Lead and scale a multidisciplinary hardware engineering organization.
• Set priorities, allocate resources, and drive performance and growth.
• Coach engineers and technicians to strengthen technical capability and leadership.
• Own end-to-end hardware project execution from concept to manufacturing transfer.
• Drive new product development and sustaining engineering of complex devices.
• Review designs, test plans, risk analyses, and documentation per medical device requirements.
• Provide technical leadership for mechanical, electrical, embedded, and software-enabled systems.
• Ensure compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and IEC 60601-1.
• Partner with Product Management, Manufacturing, Quality, Regulatory, and Supply Chain.

Skills

Leadership

Cross-functional

Hardware design

Regulatory knowledge

Architecture reviews

Education

Bachelor’s in Electrical/Mechanical/Biomedical or Systems Eng

Master’s degree (preferred)

Job description

The Hardware Engineering Director provides strategic and technical leadership for the organization’s hardware engineering function, including electrical, embedded, mechanical, and electromechanical systems.

This role leads new product development and sustaining engineering for medical devices, ensuring teams deliver innovative, manufacturable, and compliant solutions in a regulated environment.

The successful candidate will be an experienced engineering leader with strong technical judgment, disciplined execution, and the ability to build, develop, and align high-performing teams across functions.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Lead, scale, and develop a multidisciplinary hardware engineering organization.
• Set clear priorities, assign resources, establish expectations, and evaluate performance to drive accountability and professional growth.
• Coach and mentor engineers and technicians to strengthen technical capability, leadership depth, and career development.
• Own end-to-end hardware project execution, from concept development, architecture, design, prototyping, verification, and validation through transfer to manufacturing.
• Drive new product development and sustaining engineering priorities across complex electromechanical medical device platforms.
• Review and approve engineering designs, tolerance analyses, test plans, risk assessments, and design documentation in accordance with medical device requirements.
• Provide technical leadership for the design and integration of mechanical, electrical, pneumatic, embedded, and software-enabled systems.
• Oversee prototyping, bench testing, design verification, validation, and technical problem-solving activities.
• Ensure compliance with applicable regulations and standards, including FDA 21 CFR 820, ISO 13485, ISO 14971, and IEC 60601-1.
• Partner with Product Management, Manufacturing, Quality, Regulatory, Supply Chain, and Commercial teams to ensure feasibility, manufacturability, scalability, and market readiness.
• Communicate program status, technical risks, trade-offs, and mitigation plans clearly to executive leadership and cross-functional stakeholders.
• Establish engineering best practices, design standards, governance processes, and performance metrics that improve execution and decision-making.
• Identify and lead initiatives that improve product performance, quality, reliability, cost, and development efficiency.
• Perform other duties as assigned.

Competencies/Success Factors

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

Supervisory Responsibility

Provides leadership and direct supervision for electrical, embedded, and mechanical engineering teams.

This role operates primarily in a professional office environment and routinely uses standard office equipment, including 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 is expected, typically less than 5%.

Required Education and Experience

• Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, or a related engineering discipline required.
• 12+ years of progressive engineering experience, including design, development, and commercialization of complex hardware products.
• 5+ years of engineering leadership experience, including hiring, coaching, performance management, and organizational development.
• Demonstrated success leading multidisciplinary engineering teams across the full product development lifecycle, from concept through commercialization and sustaining engineering.
• Proven ability to build high-performing teams through coaching, mentoring, succession planning, and talent development.
• Experience establishing engineering processes, metrics, and organizational structures that improve execution, accountability, and cross-functional collaboration.
• Strong track record aligning engineering priorities with business objectives while balancing innovation, quality, schedule, and cost.
• Experience managing multiple concurrent development programs and allocating engineering resources across competing priorities.
• Demonstrated ability to influence executive leadership and collaborate effectively with Quality, Regulatory, Manufacturing, Product Management, Supply Chain, and Commercial organizations.
• Experience leading technical decision-making, architecture reviews, and risk management for complex hardware systems.
• Excellent communication and interpersonal skills, with the ability to build trust, align stakeholders, and lead through change.

Preferred Education and Experience

• Master’s degree in Engineering, Engineering Management, or Business Administration.
• Experience leading teams across multiple engineering disciplines, such as mechanical, electrical, and firmware engineering.
• Experience with 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.

Additional Eligibility Qualifications

None required for this position.

This job description is not intended to be a comprehensive listing of all activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change at any time, with or without notice.

The organization 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.