Advantage Technical
Research And Development Engineer -Urology (Irvine)
Advantage Technical, Irvine, California, United States, 92713
Mechanical Engineer
Acquisition & Integration Project Contract Duration:
6 months (with potential extension) Pay Rate:
Up to $69/hour Work Model:
Hybrid (3 days onsite) Preferred Locations:
Irvine, CA (primary) | Arden Hills, MN (secondary) About the Role A leading Urology Research & Development organization is seeking a highly skilled and motivated Mechanical Engineer to support an acquisition and integration initiative. This role focuses on aligning the acquired companys Design History File (DHF) with internal compliance standards. Youll assess design verification, test methods, and outputs to determine testing needs and either execute tests or update documentation to justify test waivers. Youll collaborate with subject matter experts while applying your expertise in mechanical and systems design, test method validation, verification testing, and statistical analysis. Key Responsibilities Identify gaps in DHF compliance and contribute to strategies for resolution Provide input on project goals, progress, and recommend revisions Communicate risks, trade-offs, and technical deliverables to project leadership Develop and apply new techniques for efficient integration of medical device technologies Execute engineering tasks such as: Design FMEA Design Verification test methods Test method validation DV protocols, testing, and reports Essential Design Output identification Requirements tracing Evaluate feasibility of alternative engineering processes and equipment Produce clear, concise documentation (protocols, reports, rationales) Demonstrate strong knowledge of Technology and Product Development systems Required Qualifications BS or higher in Mechanical, Biomedical, Electromechanical Engineering, or related field 4+ years of engineering experience with a bachelors degree, or 2+ years with a masters Strong mechanical/systems engineering and problem-solving skills Ability to synthesize technical inputs and make sound recommendations Excellent communication, decision-making, collaboration, and critical thinking skills High personal accountability and proactive work ethic Willingness to travel up to 10% Preferred Qualifications Experience in the medical device industry Familiarity with: IEC 14708 & 45502 (Active Implantable standards) IEC 60601 (Medical Electrical Equipment standards, including laser-specific sections) Proficiency in statistical techniques (Gauge R&R, Process Capability Studies) and Minitab Experience with single-use or active implantable device testing and validation Strong relationship-building skills across teams and with external stakeholders
Acquisition & Integration Project Contract Duration:
6 months (with potential extension) Pay Rate:
Up to $69/hour Work Model:
Hybrid (3 days onsite) Preferred Locations:
Irvine, CA (primary) | Arden Hills, MN (secondary) About the Role A leading Urology Research & Development organization is seeking a highly skilled and motivated Mechanical Engineer to support an acquisition and integration initiative. This role focuses on aligning the acquired companys Design History File (DHF) with internal compliance standards. Youll assess design verification, test methods, and outputs to determine testing needs and either execute tests or update documentation to justify test waivers. Youll collaborate with subject matter experts while applying your expertise in mechanical and systems design, test method validation, verification testing, and statistical analysis. Key Responsibilities Identify gaps in DHF compliance and contribute to strategies for resolution Provide input on project goals, progress, and recommend revisions Communicate risks, trade-offs, and technical deliverables to project leadership Develop and apply new techniques for efficient integration of medical device technologies Execute engineering tasks such as: Design FMEA Design Verification test methods Test method validation DV protocols, testing, and reports Essential Design Output identification Requirements tracing Evaluate feasibility of alternative engineering processes and equipment Produce clear, concise documentation (protocols, reports, rationales) Demonstrate strong knowledge of Technology and Product Development systems Required Qualifications BS or higher in Mechanical, Biomedical, Electromechanical Engineering, or related field 4+ years of engineering experience with a bachelors degree, or 2+ years with a masters Strong mechanical/systems engineering and problem-solving skills Ability to synthesize technical inputs and make sound recommendations Excellent communication, decision-making, collaboration, and critical thinking skills High personal accountability and proactive work ethic Willingness to travel up to 10% Preferred Qualifications Experience in the medical device industry Familiarity with: IEC 14708 & 45502 (Active Implantable standards) IEC 60601 (Medical Electrical Equipment standards, including laser-specific sections) Proficiency in statistical techniques (Gauge R&R, Process Capability Studies) and Minitab Experience with single-use or active implantable device testing and validation Strong relationship-building skills across teams and with external stakeholders