Job Details

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: Bachelors 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.