Partnering closely with senior leadership to define product strategy and long-term technical direction
Partner with PMO and Project Managers to assign resourcing, prioritizing, initiating, and planning technical programs for approved projects
Responsible for technical program outcomes
Leading technical staff working with cross-functional teams including Embedded Development team, Software Development team, and IoT Communication Development Team to deliver embedded medical systems
Providing leadership and direction to technical team, guiding them through the stages of requirements definition, design, implementation, and validation to achieve coherent and efficient system architecture
Leading the completion of complex cross-functional programs having major importance to the organization
Energizing work groups by creating a climate which encourages innovation, risk taking, teamwork, and high productivity
Working collaboratively with multiple functions and/or organizations
Maintaining a strong operational knowledge of organization’s technologies, products, customers and customers’ needs
Developing an in-depth knowledge of product development, manufacturing, engineering, financial, legal, sales and marketing functions and interfaces as required
Facilitating and generating appropriate intellectual property protection plans for product development
Managing product documentation through Change Order and Release processes
Participating in all reasonable work activities deemed suitable and assigned by management.
Conforming to, supporting and enforcing all Company policies and procedures.

Requirements

Bachelor’s degree or higher in engineering from an accredited institution or equivalent experience through training
12 years combined industry experience in embedded device development and/or product design in a regulated industry OR High School Diploma/GED and 16 years combined industry experience in embedded device development and/or product design in a regulated industry AND 7 years of management experience leading product development teams in a regulated industry
Demonstrated history of contributions to an organization through management of resources on major impact programs
Experience in a regulated design environment with medical device development, FDA or ISO registered work experience
Experience in GMP certified Manufacturing Processes and UL, IEC Standards
Hands on experience in System Engineering with working knowledge of negative pressure application, C or C++ embedded systems, IoT Communication, and Cybersecurity risk management
Define and own system requirements, architecture, integration, and testing through all review stages up to final verification and validation
Drive continuous improvement of processes, tooling, and technical deliverables
Run technical working sessions and engineering reviews
Self-driven, problem solving and critical thinking skills
Identify, quantify, and mitigate technical risks
Excellent collaboration skills.

Benefits

Medical
Dental & Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Voluntary Benefits
Paid Absences
Retirement Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

embedded device developmentproduct designSystem EngineeringC programmingC++ programmingIoT CommunicationCybersecurity risk managementrequirements definitiondesign implementationvalidation

Soft Skills

leadershipcollaborationproblem solvingcritical thinkinginnovationteamworkhigh productivityresource managementcommunicationrisk management