Senior Director, Hardware Engineering — Medical Devices

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

Job summary

Confidential Careers seeks an experienced Hardware Engineering Director to lead a multidisciplinary hardware organization across electrical, embedded, mechanical and electromechanical systems for medical devices.

The role centers on strategic leadership, new product development, and sustaining engineering in a regulated environment, driving manufacturability, quality, and compliance while building high‑performing teams across functions.

Qualifications

• Bachelor’s degree in Electrical, Mechanical, Biomedical or Systems Engineering (or related field).
• 12+ years of progressive engineering experience, including design, development and commercialization of hardware products.
• 5+ years of engineering leadership, including hiring, coaching, performance management and org development.
• Experience leading multidisciplinary teams across the full product lifecycle from concept to sustaining engineering.
• Proven ability to build high-performing teams through coaching, mentoring and succession planning.
• Experience establishing engineering processes, metrics and org structures for better execution and collaboration.
• Strong track record aligning engineering priorities with business objectives while balancing innovation, quality, schedule and cost.
• Experience managing multiple concurrent development programs and resource allocation.

Responsibilities

• Lead, scale, and develop a multidisciplinary hardware engineering organization.
• Own end-to-end hardware project execution from concept to manufacturing transfer.
• Drive new product development and sustaining engineering for complex medical device platforms.
• Review designs, analyses, risk assessments, and documentation per medical device requirements.
• Provide technical leadership for mechanical, electrical, pneumatic, embedded, and software-enabled systems.
• Ensure regulatory compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601-1.
• Collaborate with Product Management, Manufacturing, Quality, Regulatory, Supply Chain, and Commercial teams.
• Communicate status, risks, and mitigation plans to executive leadership and cross-functional stakeholders.
• Establish engineering best practices, design standards, governance, and metrics.

Skills

Project/Task Management

Mechanical Skills

Results Focus/ Output Orientation

Team Orientation

Interpersonal Communication

Coaching/ Developing Others

Leadership

Education

Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, or related engineering discipline

Master’s degree in Engineering, Engineering Management, or Business Administration

Job description

Confidential Careers seeks an experienced Hardware Engineering Director to lead a multidisciplinary hardware organization across electrical, embedded, mechanical and electromechanical systems for medical devices.

The role centers on strategic leadership, new product development, and sustaining engineering in a regulated environment, driving manufacturability, quality, and compliance while building high‑performing teams across functions.