Director of Hardware Engineering

Overview:

Our client is seeking a Director of Hardware Engineering. Preference will be given to a person with experience in the medical devices vertical. You are a “hands on leader “with broad experience of developing electro-mechanical products for the medical device industry through development and into production. You will work closely with the System and Software Engineering teams. Additionally, you will strongly collaborate with: Program Management, Product Management, Quality, Regulatory and Supply Chain. You will report into a Vice President.

• Hardware development is a hands-on activity that requires an in-office presence, however, there is flexibility to work from home pending commute length and project activities that can be efficiently completed from home. Limited travel.

Your Responsibilities:

• You will add new hires  and manage an engineering team that consists of mechanical, electrical, integration and manufacturing engineers
• You will lead the technical team completing program deliverables per target timelines, scope and budget
• You will mentor junior engineers
• You will create and enforce good engineering practices for deliverables including subsystem requirements, risk management, design descriptions, mechanical and electrical CAD/drawings, design for manufacturability, design for reliability and integration activities

Required Experience:

• Hands-on mechanical and/or electrical engineering with  past experience to guide new product design and resolve technical issues for product in the field
• Serve as a primary technical interface with external product development customers and external contractors
• Collaborate with the software and system engineering teams to ensure the system hardware design reflects the intended system architecture
• Ensure hardware deliverables are consistent with the Quality Management System and are in support of regulatory submissions
• Leverage prior manufacturing experience to ensure smooth transfer to manufacturing and help to resolve technical issues involving supply chain

Project Management Skills:

• Facilitate progress with the right mix of Agile methods and Waterfall deliverables.
• Work with Program Management to define and document program scope, constraints and assumptions in detailed integrated program/project plans including schedule, resource needs, and budget
• Generate and communicate metrics of progress for the engineering programs and projects
• Establish and maintain a coherent perspective of program and technical risk and drive execution against risk mitigation plans as required to achieve program objectives and resolve technical issues
• Hold team members accountable for areas of responsibility to the program team and ensure support and focus on program objectives
• Contribute to technical summaries and resource estimates during RFP generation for new projects

Experience:

• Relevant engineering degree. An  advanced degree is  preferred
• Minimum of 15 years’ experience with system-level product design
• Minimum of 10 years as a lead mechanical, electrical engineer, system architect or chief engineer on new product development
• Minimum of 5 years medical device development experience, including successful 510k submission, or higher
• Design transfer of at least 1 product to manufacturing
• Experience with systems involving electro-mechanical, software, user interface and disposable designs
• Excellent working knowledge of medical device development processes and engineering deliverables
• Innovative thinker who can make sound technological decisions while making necessary technological tradeoffs
• Mastery of relevant hardware engineering tools including mechanical and/or electrical CAD
• Demonstrated capability for managing multiple engineering programs with shared resources

Applicants must be authorized to work in the United States legally.