Katalyst CRO ยท 1 day ago
Mechanical Engineer
Cincinnati, OH
Contract
Onsite
Mid LevelKatalyst CRO is focused on medical device engineering, and they are seeking an Electro-Mechanical Engineer to lead electrical engineering activities for sustaining and legacy products. The role involves resolving component obsolescence, ensuring compliance with regulatory standards, and collaborating with cross-functional teams for design improvements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Lead electrical engineering activities for sustaining and legacy medical device products
Investigate and resolve electrical component obsolescence, supplier changes, and field issues
Perform root cause analysis and implement corrective and preventive actions (CAPA)
Support design changes, verification and validation activities, and documentation updates in compliance with regulatory standards
Collaborate with cross-functional teams to ensure timely issue resolution and design improvements
Participate in risk assessments (FMEA), design reviews, and change control processes
Provide technical support to manufacturing, test engineering, and quality assurance teams
Maintain and update technical documentation including schematics, BOMs, test protocols, DHF, DMR, and reports
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 60601, and internal quality systems
Qualification
Required
Lead electrical engineering activities for sustaining and legacy medical device products
Investigate and resolve electrical component obsolescence, supplier changes, and field issues
Perform root cause analysis and implement corrective and preventive actions (CAPA)
Support design changes, verification and validation activities, and documentation updates in compliance with regulatory standards
Collaborate with cross-functional teams to ensure timely issue resolution and design improvements
Participate in risk assessments (FMEA), design reviews, and change control processes
Provide technical support to manufacturing, test engineering, and quality assurance teams
Maintain and update technical documentation including schematics, BOMs, test protocols, DHF, DMR, and reports
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 60601, and internal quality systems
Experience with circuit design, PCB layout, and embedded systems
Hands-on experience with microcontrollers, sensors, drivers, and electrical testing
Knowledge of MATLAB and LabVIEW
Strong understanding of medical device regulations and standards including IEC 60601, ISO 13485, and FDA 21 CFR Part 820
Experience with risk management (FMEA), CAPA, sustenance engineering, and design control
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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