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MillenniumSoft Inc · 4 months ago

Staff Process Engineer (Hardware) - Remote

United States

Full-time

Remote

Senior Level

5+ years exp

MillenniumSoft Inc is a Medical Devices Company seeking a highly skilled Staff Process Engineer (Hardware) to define and implement hardware design processes that adhere to regulatory standards. The role involves leading cross-functional teams, remediating design control documentation, and driving continuous improvement efforts within the hardware engineering domain.

Staffing & Recruiting

No H1B

U.S. Citizen Only

Responsibilities

Develop or modify and implement Electrical, Mechanical, and Test hardware design documentation templates within the Quality Management System that comply with industry standards and regulations. Clearly demonstrate end-to-end traceability where hardware design control elements are included, and remediate gaps and errors as needed

Translate business and regulatory requirements into comprehensive hardware development processes

Work collaboratively to ensure alignment with additional stakeholders, development teams, and business objectives

Maintain frequent and clear communication with team members and leaders working in all areas of the project. Identify risks and issues early on and implement mitigations as necessary

Facilitate effective knowledge sharing and collaboration across departments (e.g., Systems Engineering, Software Engineering, Test Engineering, Quality, and others) to resolve alignment or feasibility issues

Communicate relevant project information effectively (verbal and written) including project status, technical concepts and design details, and functional demonstrations to key internal and external stakeholders of varying technical abilities

Identify and drive opportunities for process improvement within the Hardware and Test Engineering functions to enhance efficiency, quality, clarity, and compliance

Serve as a resource for addressing and resolving issues of process and documentation

Apply best practices from methodologies like DFSS (Design for Six Sigma) and an Agile mindset to all projects

Review and remediate hardware design control documentation

Qualification

Hardware EngineeringRegulatory StandardsDesign Control ManagementQuality EngineeringCross-Functional CollaborationContinuous ImprovementTechnical ExpertiseLeadershipCommunication SkillsOrganizational Skills

Required

Bachelor's degree in Science or Engineering is required

Minimum of 5 years of related work experience in hardware engineering

Experience with regulatory standards (e.g., IEC 62304, FDA guidance, IEEE standards) in a regulated industry is highly preferred

Demonstrated ability to lead multi-disciplinary engineering teams and serve as a technical leader within the organization

Positive attitude with an aptitude for critical thinking

Willingness to learn and adapt to new challenges

Strong organizational skills, ability to work independently and with a group

Ability to handle multiple tasks simultaneously and prioritize workload

Strong background in hardware engineering, requirements management, and implementation of test processes

Experience in hardware product development, including user needs assessment, hardware system analysis and decomposition, architectural design, integration and testing, etc

Extensive experience in the creation and maintenance of design and development documentation

Exceptional communication skills, both interdepartmental and cross-functional

Strong writing abilities and attention to detail are essential