Description:
We are seeking a highly-skilled, driven, and experienced Staff Process Engineer (Hardware) with expertise in defining and implementing hardware design processes and design control deliverables that adhere to regulatory standards within the medical device industry. This role requires a strong technical background in Electrical, Mechanical, or Test/Reliability Engineering, leadership capabilities, and extensive experience in product design and development. Experience in Quality and/or Systems Engineering is also a plus.
The engineer will play a critical role in shaping the process for defining and documenting hardware-centric design control elements and deliverables, ensuring alignment with regulatory requirements such as FDA guidance, and meeting both user and business needs. They will also be remediating the design control documentation for accuracy, completeness, and clear upstream and downstream traceability from hardware-centric design control elements. The ideal candidate will drive continuous improvement efforts, collaborate across multi-disciplinary teams, and provide technical expertise to ensure successful project outcomes.
Key Responsibilities:
- Hardware Design Documentation Remediation: 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.
- Leadership: 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.
- Cross-Functional Collaboration: 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.
- Continuous Improvement: Identify and drive opportunities for process improvement within the Hardware and Test Engineering functions to enhance efficiency, quality, clarity, and compliance.
- Technical Expertise: 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.
Minimum Qualifications:
- Bachelor’s degree in Science or Engineering is required; a postgraduate degree is preferred.
- 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
- 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
- Experience in Quality engineering and design control management is a plus
- Experience with ALM/PLM and/or CAD tools is a plus
