Overview
Staff Process Engineer (Hardware) - Remote at MillenniumSoft Inc. Position: Staff Process Engineer (Hardware) - Remote. Location: San Diego, CA. Duration: 12 Months. Total Hours/week: 40. 1st Shift. Employment Type: Contract on W2 (US Citizens or GC Holders or GC EAD or OPT or EAD or CPT). Client: Medical Devices Company. Job Category: Engineering. Level of Experience: Senior - Level.
This is a remote position with occasional travel up to 10% to support workshops and intensives. The role requires defining and implementing hardware design processes and design control deliverables that comply with regulatory standards within the medical device industry.
Responsibilities
Define and implement hardware design processes and design control deliverables that adhere to regulatory standards within the medical device industry.
Lead remediation of hardware-centric design control documentation for accuracy, completeness, and clear upstream and downstream traceability.
Drive continuous improvement of hardware and test engineering processes; collaborate across multidisciplinary teams to ensure successful project outcomes.
Translate business and regulatory requirements into comprehensive hardware development processes and maintain alignment with stakeholders and development teams.
Facilitate cross-functional collaboration (Systems, Software, Test, Quality, and others) to resolve alignment or feasibility issues and communicate project status clearly to stakeholders.
Apply best practices from DFSS and an Agile mindset to projects; address process and documentation issues as a resource for the organization.
Qualifications
Education: Bachelor’s degree in Science or Engineering required; postgraduate degree preferred.
Experience: Minimum of 5 years in hardware engineering; experience with regulatory standards (e.g., IEC 62304, FDA guidance, IEEE standards) in a regulated industry is highly preferred.
Leadership: Demonstrated ability to lead multi-disciplinary engineering teams and act as a technical leader; strong organizational skills; ability to work independently and collaboratively; ability to manage multiple tasks and priorities.
Technical Skills: Strong background in hardware engineering, requirements management, and implementation of test processes; experience with hardware product development from user needs assessment to testing; experience with design documentation; knowledge of ALM/PLM and CAD tools is a plus; experience in Quality engineering and design control management is a plus.
Communication: Exceptional written and verbal communication skills; ability to convey technical concepts to stakeholders with varying levels of technical ability.
Note: This description reflects information provided in the original posting and is focused on the responsibilities and qualifications for the role.
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