Advantage Technical
Research And Development Engineer -Urology
Advantage Technical, Minneapolis, Minnesota, United States, 55400
Research And Development Engineer - Urology
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)
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 company’s Design History File (DHF) with internal compliance standards. You’ll assess design verification, test methods, and outputs to determine testing needs and either execute tests or update documentation to justify test waivers.
You’ll 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
Requirements tracing
Evaluate feasibility of alternative engineering processes and equipment
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 bachelor’s degree, or 2+ years with a master’s.
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.
Seniority Level
Mid-Senior level
Employment Type
Contract
Job Function
Medical Equipment Manufacturing
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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)
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 company’s Design History File (DHF) with internal compliance standards. You’ll assess design verification, test methods, and outputs to determine testing needs and either execute tests or update documentation to justify test waivers.
You’ll 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
Requirements tracing
Evaluate feasibility of alternative engineering processes and equipment
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 bachelor’s degree, or 2+ years with a master’s.
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.
Seniority Level
Mid-Senior level
Employment Type
Contract
Job Function
Medical Equipment Manufacturing
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