Product Development Manager
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Description
Act as the technical project manager with overall responsibility for the management, performance, and completion of product hardware and software development projects- Create and track project schedules, budgets, risks, and quality policy adherence with the support of technical contributors
Provide leadership and guidance to hardware and software development teams in meeting the safety, quality, manufacturing, cost, regulatory requirements, and innovative strategies and solutions
Drive the creation of technical specifications, design specifications, and system validation plans to meet project deliverables in accordance with design controls
Coordinate with the Quality Team to assist in the authoring of the design history file, technical files, and quality engineering documentation
Oversee the planning and adherence to design and development plans and phases for software-based and hardware-based projects
Use structured problem-solving methodologies to identify root cause and effective corrective and preventative actions to mitigate risks
Conduct regular business, technical, and design review meetings
Manage and coordinate supply chain logistics and infrastructure
Publish and present status reports to managers and team members
Provide product support to customers and customer support teams
Requirements
2 years of experience in product development and development project management
5 years of software development, hardware engineering, and electronic product manufacturing processes
Development and management of technical file and non-clinical modules for Class II devices
Extensive working knowledge of ISO 13485:2016, IEC 60601, IEC 62304
Comprehensive knowledge of electronic hardware and software-based development and manufacturing practices
Educational background in electrical, industrial, mechanical, or healthcare engineering
Extensive understanding of design controls and waterfall-based hardware and software project management
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