Electrical & Software Engineering Manager
IMPACT and OPPORTUNITY
The Electrical and Software Engineering Manager is a working / supervisory position that oversees and delivers medical product development-related projects and ensures all products and documentation comply with customer and regulatory requirements. He/She will manage several direct reports and provides technical support to internal customers and is expected to work directly with external customers as required. Typically, work is performed with minimal general supervision from the Engineering Director or, on an as-needed basis, in order to surpass specific project hurdles. The Manager is responsible to plan and perform duties as assigned to him/her, as well as function as the “subject matter expert” and “consultant” to the electrical and software engineering teams by leveraging technical expertise and experience. The Manager is responsible for leading a team of electrical and embedded software engineers and for providing ongoing mentorship to junior level staff and co-operative education interns.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
● Oversee daily activities of a team of electrical and embedded software engineers.
● Create new product architectures working closely with lead electrical and lead software and lead mechanical team members.
● Familiar with Electrical Engineering principles and experience in problem-solving items like new product development, component selection, circuit design, risk-based evaluation for alternatives and obsolescence, and technical specification development.
● Familiar with embedded software design and review process and hardware interfacing options.
● Understands fundamental electrical troubleshooting on PCBA’s, switching and isolation power supplies, displays, batteries, and connectivity solutions
● Understands software development best practices and oversees programming standards and sprint assignments.
● Assures that product design meets UL, CE, and FDA requirements, as well as all international regulatory requirements.
● Responsible for overseeing the creation/maintaining/approving product’s design history files.
● Participate in, and sometimes leads, cross-functional project team activities to assure designs are manufactured to meet or preferably exceed customer. requirements, in high quality, cost effective, and timely manner.
● Approve test protocols and test reports and product /process documentation.
● Document designs and analyses per FDA 510k certification process, including hardware requirement, hardware detailed design, DFMEA, Risk Analysis and Verification & Validation.
● Experienced in Design Transfer to local and contract manufacturing for production.
● Embrace and lead continuous process improvements in the New Product Development staged gate system.
● Bachelor’s Degree in Electrical Engineering
● 10+ years of experience in the Medical Device (class II) Industry with multiple successful product launches
● Experience architecting, implementing, and maintaining an Embedded Linux image preferred (Yocto, Wind River)
● Leadership experience of direct reports (min 3)
● Program Management experience
● Thermal Management experience
● Simulation experience electrical\thermal
TRAVEL: Up to 10%, Domestic.
● Set annual performance goal metrics and reviews.
● Establish subordinate individual development plans for career growth.
● Active engagement with the team for support and mentoring.
● Deliver Results
◦ Understand the mission and output of your team; set SMART objectives and deliver
● Drive Change
◦ Focus on agility and commitment to continuous improvement; Understand and act on internal and external drivers of change
● Build Capability
◦ Foster a culture of learning and development; Support individual growth through continuous feedback to achieve personal and professional goals
● Cultivate Innovation
◦ Openly embrace, create, implement and support new and innovative ideas, processes, and technology that deliver business results
PHYSICAL DEMANDS/WORK ENVIRONMENT (US):
All positions in our office require interaction with people and technology while either standing or sitting. In order to best serve our customers, internal and external, all associates must be able to communicate face-to-face and on the phone with or without reasonable accommodation. We are committed to compliance with its obligations under all applicable state and federal laws prohibiting employment discrimination. In keeping with this commitment, it attempts to reasonably accommodate applicants and employees in accordance with the requirements of the disability discrimination laws. It also invites individuals with disabilities to participate in a good faith, interactive process to identify reasonable accommodations that can be made without imposing an undue hardship.