Engineer, Design Quality

Job Title:

Engineer, Design Quality

Reporting to:

Global Vice President, Quality and Regulatory

Location:

San Jose, California

Job Site:

On-Site

Job Description Revision Date:

January 2025

About us:

We know what it takes to be a key partner in life science and medical industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments, software, and consumables. Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 is a growing company with offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Costa Rica.

We are seeking a results-driven individual to join our growing organization in San Jose, California facility.

Job Summary:

Provides hardware design quality engineering expertise to R&D and customers, as well as guidance to other departments, as necessary, on matters regarding compliance to U.S. and international related regulations and standards. The quality engineer is looking into current issues with product and related design processes. This includes analysis of complaints or non-conformance reports, updating technical files as well as analysis of manufacturing process related data. The quality engineer is part of an engineering team which is working in a regulated environment.

Job Details:

• Lead proactive design assurance activities facilitating the development and release of high-quality products.
• Review and approve product design documents- in accordance with design controls standards and the Company's policies.
• Support audits and compliance assessments of DHF and other program files to ensure quality and regulatory requirements are met.
• Participate in cross-functional teams to resolve reliability issues as they arise
• Develop quality processes and assist in implementation, especially for design and development.
• Partnering with R&D; ensures design control processes are maintained and continuously improved to ensure on-going compliance to all applicable regulation and standards.
• Assure proper documentation and execution of design planning, inputs and outputs, design review, V&V, risk analysis and design change per company and regulatory requirements.
• Identify and provide guidance for the application of harmonized standards to product development.
• Set quality assurance testing models for analysis of raw materials, materials in process, and finished products
• Incorporate feedback on manufacturability, safety compliance and customer response into product requirements
• Perform or coordinate failure analysis and field performance investigations.
• Lead complaint root cause analysis and recommend related improvements.

Knowledge and Training:

• Expertise in analyzing, troubleshooting and resolving complex issues.
• A strong commitment to product excellence.
• Ability to balance the needs of a fast-paced start-up environment with the needs for good documentation and quality control.
• Strong understanding of IEC 60601 and requirements for compliance.
• Knowledge and competency in application of FDA, ISO 13485, ISO 14971, MDR, and other regulatory requirements, especially in the area of quality systems and design control as applied to projects from design inception to manufacturing release, is required.
• Experience with the following techniques: Hazard Analysis, Risk Analysis, FMEA.
• Experience with medical electronic products development including hardware design, verification, and validation phases.
• Experience in hardware bring-up, characterization and failure analysis.
• Experience with the full product life-cycle (Concept, Specification, Design, Verification, Manufacturing & Sustaining).
• A demonstrated ability to create comprehensive test strategies and plans based on design specs.

Experience:

• Minimum 10 years engineering experience and 10 years quality experience in regulated industry (medical device).
• Small Company experience a bonus.

Education:

• Bachelor's in Electrical Engineering, Mechanical Engineering, or related degree.

Company Benefits:

Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.