DermaSensor, Inc Production and Quality Engineering Manager Remote · Full time Company website

Apply for Production and Quality Engineering Manager

The Production and Quality Engineering Manager shall be responsible for performing the duties of quality engineering and manager of contracted development and manufacturing for the company by performing the following responsibilities:

• Product Manufacturing 
• Manage contract manufacturer production planning and scheduling for on-time delivery of products to supply chain.
• Identify and address key concerns that may alter or impact production schedule.
• Investigate product change orders and review sustaining engineering plans.
• Track development milestones to meet established deadlines.

• Product Development 
• Source and coordinate with vendors and suppliers of development and engineering services to plan, monitor, and collaborate on development sprints and phases for software and hardware.
• Oversee feedback collection and implementation into new and existing product development plans within cost parameters.
• Create and track project schedules, budgets, risk level, and quality policy adherence with support of hardware and software development team members. 
• Oversee and manage daily activities of contract engineering partners for design and development plans of current and future products. 

• Quality Engineering
• Act as the technical project manager for hardware and software design and development projects to develop and maintain appropriate documentation including design and development plans, risk management reports, design history files, work instructions, verification and validation protocols and reports, risk management, design & development documents, labeling, and other documentation related to change controls.
• Work with engineers to conduct testing per test protocols and develop test reports. Complete traceability of requirements to tests. 
• Use structured problem-solving methodologies to identify root cause and effective corrective counter measures to mitigate risks
• Ensure that all appropriate Software Verification & Validation activities are followed including that low-level unit testing is adequate to the level of concern and that all configuration management, build, release, and version control methods are followed.
• Conduct regular technical and design review meetings with other quality team members. 
• Author and maintain quality system documents, product quality inspections, and participate in quality audits. 
• Publish and presents project status reports to managers and team members.
• Develop product support resources for customers and customer-support teams.

Requirements

• Working knowledge of FDA QSR, ISO 13485, ISO14971, ISO 60601, 62304, SaMD, Cybersecurity and EUMDR regulations.

• Comprehensive knowledge of electronic hardware and software-based development and manufacturing practices.

• A degree in a science or engineering discipline (preferably an educational background in electrical, industrial, mechanical, or healthcare engineering

• Self-sufficient and able to work and make decisions independently

• Thorough knowledge of project management and planning for software development, product development manager software, and quality management systems.

• Strong analytical and problem-solving skills

• High attention to detail including proven ability to manage multiple, competing priorities simultaneously

• Collaborative, team-first attitude – maximizing team performance and value ideas on their merits

• Ability to collaborate with team members under pressure and iterate quickly

• Strong interpersonal and leadership skills

• Superior verbal and written communication skills