Director, Electronics

OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Director, Electronics responsible for the planning, management, and execution of electronics and software-related activities and development of new products and technologies. While keeping current on technological trends to create unique and effective products, this role maintains current specifications/BOMs/processes, while managing costs. This role manages the electronics team to ensure product development and electronics sustaining/support deadlines remain top priority and are consistently met. To ensure capacity to achieve new product goals, this role understands the pulse of the team to maintain staffing at appropriate levels with top talent.

You will:

• Design and Development: Lead the creation, design and development of embedded systems, hardware and software, ensuring they meet project requirements. Drive new product development efforts and supports efforts sustaining released products including support for complaint investigations, supply chain and other issues.
• Documentation: Maintain detailed documentation of the development process in line with electronics design control procedures.
• Collaboration: Work closely with hardware engineers, software developers, and other team members to integrate systems effectively. Ensure Agile methodology is followed and expanded in the course of electronics development.
• Software Releases: Manage staff to ensure the organization and planning of software releases in line with product release calendar and software update schedules. Manage the compilation of desired feature sets with product marketing and product development engineering. Coordinate the compilation of software and embedded systems 'fixes' and enhancements in response to complaints, CAPAs. Marketing and other inputs. Generate a software projects list and calendar within the Project Steering Committee with careful consideration of timing, resource allocation, financial budgets and business efficiencies, updating periodically to meet the needs of the business. Proactively identify and communicate bottlenecks and breakdowns.
• Management: Provide high level updates to leadership. Support strategic planning. Provides guidance and mentorship to staff. Ensures project staffing needs are adequately assessed and planned. Recruit and retain top talent. Manage staff, providing direction and feedback. Manage interface between software/embedded systems and cross-functional teams to ensure system level requirements are understood and fulfilled. Perform other duties as assigned. Provide point person interface with field and commercial personnel with respect to field issues, technical questions and needs.

You need:

• Your BS degree and 10+ years of experience, or without degree 15+ years, in progressive software development and management
• Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint)
• Excellent written and verbal communication skills
• Results-oriented with appropriate urgency
• Ability to work as a collaborative team member as well as independently - expert in Sprint Tactics
• Excellent attention to detail, producing high quality output
• Flexibility and strong organizational skills with ability to prioritize multiple tasks
• Applies sound judgment when making decisions and communicating with internal and external customers
• Up to date on software and firmware development including Android, C/C++, Python, Sockets, Unix Shell, Matlab
• Experience in a highly regulated FDA medical device environment
• Strong project management experience
• Agile methodology
• Leadership and confidence
• Android SW Development or Java development
• Agile SW Development, Scrum methodology
• Software Development Lifecycle appropriate for med device
• Software Requirements Management
• Test strategy planning and implementation
• Hardware/Software Integration
• Human Factors/User Needs
• Cybersecurity
• Understanding of IEC-62304 and compliance
• Familiarity with ISO 14971
• Software Engineering Technical Mentorship

We offer:

• Competitive compensation including bonus and equity
• Opportunities for career advancement
• Full benefits package
• An evolving, engaging culture and workplace
• Nominated by our employees as a Top Place to Work in Orange County!

It is an exciting time at OrthAlign - make your next career move with us!

Please note that we are unable to provide any type of sponsorship at this time.

No recruiters, please.