Staff Mechanical Engineer

Job Description

Job Description

Company & Job Overview:

Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease.

As a Staff Mechanical Engineer, you will bring deep technical expertise and leadership to our engineering team, driving innovation, ensuring compliance with regulatory standards, and contributing to the success of our projects.

Responsibilities:

• Provides solutions to various issues in creative and effective ways.
• Understands and works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exhibits advanced wide-ranging experience, using in-depth professional knowledge, acumen, concepts, and company objectives to develop, resolve complex models and procedures.
• Leads the development of mechanical system and component designs, including planning, and cross-functional coordination.
• Is a key stakeholder in defining project plans and helps anticipate and mitigate risks to project success.
• Accountable to ensure product features, performance, reliability and quality are met within the cost budget and delivered on time.
• Owns the creation and completion of hardware requirement documents.
• Designs mechanical components, parts, assemblies and systems of significant complexity.
• Creates component and assembly drawings including complex modeling and dimensioning.
• Generates complete BOMs and build packages, works with manufacturing and external suppliers on fabrication and build processes ensuring design for manufacturability
• Considers complex and dynamic tradeoffs when implementing design.
• May lead issue resolution of advanced/complex technical issues.
• May lead system safety, shock and vibration, shipping, environmental, biocompatibility, mechanical, fluidics and reliability testing.
• Applies risk, failure analysis, and root cause analysis as required within the engineering discipline.
• Works with production to ensure manufacturability and testability of mechanical designs and sub-systems.
• Ensures all the design activities and documents meet the regulatory and QMS requirements.
• Collaborates closely with other departments, including regulatory affairs, quality assurance, manufacturing, and marketing, and other engineering functions to ensure alignment on project objectives and priorities.
• Communicates effectively with stakeholders at all levels of the organization to drive consensus and facilitate decision-making.
• Responsible for leading and presenting technical documentation for system design reviews and phase gate reviews.
• Identify opportunities for process improvements, cost reductions, or efficiency gains within the engineering function.
• Can be given complex tasks without supervision and is responsible for the engineering function deliverables.
• May be a technical lead for sub-system design that may include cross-functional team members.
• Provides guidance and mentorship to junior engineers, sharing insights, best practices, and lessons learned from previous experiences.
• Actively participants in technical issues and leads cross-functional teams for root cause investigations.

Qualifications & Requirements:

• Bachelor’s degree in biomedical, electrical, mechanical, systems or software engineering.
• Minimum 8 years of related experience or 6 years and a Master’s degree in engineering.
• Has in depth understanding of system architecture design and is a subject matter expert in multiple system or sub-system design related core competencies.
• Working knowledge of medical device regulations and standards (e.g., FDA QSR, ISO 13485, ISO 60601, ISO 14971), providing guidance on interpretation and implementation to ensure compliance.
• Demonstrable experience in advanced mechanical engineering principles and applications.
• Expert in ANSI standards, material tolerancing and tolerance analysis. Experience using advanced tolerance analysis tools. Understands impact of tolerances to performance, assembly, qualification, inspection and cost.
• Expert experience in the creation of plastic parts including injection molding and vacuum forming of complex parts. Experience in mold design, mold flow analysis and various material types, design for cost effectiveness. Experience with second operations with plastic parts including inserts, welding, bonding.
• Expert experience in the creation of metal parts including sheet metal, die casting, investment casting, extrusion and machining.
• Strong knowledge of structural analysis and thermal and fluid dynamics.
• Ability to build and test prototype systems, including writing and executing verification protocols.
• Able to conduct FEA and basic CFD analysis.
• Experience with mechanism and component design.
• Expert experience with solid modeling tools (Solidworks).
• Experience with design for manufacturability including manufacturing requirements, test fixtures and systems, demonstrated ability to take designs through full product life cycle.
• Expert knowledge of IEC60601 series standards, experience with test and troubleshooting of mechanical and thermal safety.
• Understanding of Medical Device QMS and design control, familiar with PDM/PLM system and change control process.
• Strong problem-solving skills and the ability to develop innovative engineering solutions to complex technical challenges.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with diverse teams and stakeholders.
• Demonstrated leadership capabilities, with experience leading cross-functional teams, projects, and initiatives to successful outcomes.
• Proven ability to drive results and meet project timelines while maintaining high standards of quality and compliance.
• Self-motivated and proactive attitude with a willingness to learn and adapt to new challenges, provide recommendations for continuous improvement.
• Passion for improving healthcare through innovative technology solutions.

Physical Demands:

• Sustained periods of time standing and sitting in a laboratory
• Sitting at a desk utilizing a computer
• Some lifting of<25 pounds

Working Environment:

• Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.

Travel:

• Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.