Katalyst CRO ยท 2 weeks ago
Manufacturing Engineer
Cleveland, OH
Contract
Onsite
Mid Level
3+ years expKatalyst CRO is seeking a Manufacturing Engineer with medical device experience to support and improve manufacturing processes in a regulated environment. The role involves developing and optimizing manufacturing processes, supporting new product introductions, and ensuring compliance with FDA and ISO requirements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Develop and optimize manufacturing processes
Support new product introductions and production scaling
Perform process validations (IQ/OQ/PQ)
Troubleshoot manufacturing issues and drive continuous improvement
Ensure compliance with FDA, ISO 13485, and GMP requirements
Collaborate with Quality, R&D, and Operations teams
Qualification
Required
Seeking a Manufacturing Engineer with medical device experience to support and improve manufacturing processes in a regulated environment
Develop and optimize manufacturing processes
Support new product introductions and production scaling
Perform process validations (IQ/OQ/PQ)
Troubleshoot manufacturing issues and drive continuous improvement
Ensure compliance with FDA, ISO 13485, and GMP requirements
Collaborate with Quality, R&D, and Operations teams
Bachelor's degree in Engineering or related field
3+ years manufacturing engineering experience in medical devices or regulated industry
Knowledge of FDA regulations, GMP, and process validation
Strong problem-solving and communication skills
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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