Cirtec Medical ยท 3 hours ago
Sr. Manufacturing Engineer
Cirtec Medical has been a leading outsourcing partner for complex medical devices for over three decades. The Sr. Manufacturing Engineer is responsible for developing and implementing manufacturing processes that meet Class III medical device quality standards, while also leading continuous improvement initiatives and supporting new product launches.
ManufacturingMedical Device
Responsibilities
Implement, plan, and execute continuous improvement projects for cost reduction, quality improvements and efficiency from conception to fully established production
Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance
Help product development with the manufacturing launch of new products including evaluating yield targets, run rates, training needs and quality results
Prepare engineering change orders and coordinates the deployment of changes including training Operations team members
Perform product and process analysis for cost reduction, quality improvement and improved efficiency
Utilize tools associated with risk management (PFMEA/Hazard Analysis) to identify potential risks and the associated corrective actions
Support required equipment installation qualifications, process validations, and retroactive legacy qualifications or validations
Troubleshoot processes when defects occur. Help to determine root cause and implement effective containment and countermeasures
Active participant in Material Review Board (MRB). Help to lead Non-Conforming Material Report (NCMR) or customer complaint investigations
Develop, test, and provide ROI cost justification for various tools or equipment recommended for manufacturing
Disposition non-conforming products and develop re-work procedures
Communicate with customers regarding process improvements and requested production changes
Represent manufacturing on cross functional teams
Participate in Kaizens and drive improvement efforts
Qualification
Required
A Bachelor's degree in a STEM engineering discipline
5 years of experience required in a Manufacturing Engineering role
Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred)
Advanced knowledge of manufacturing and assembly processes
Previous experience with the ability to direct, lead and mentor engineers with respect to company engineering procedures, new product introduction, manufacturing support and tooling
Excellent verbal and written communication skills
Must be able to read, write and speak fluent English
Ability to lead, train, and engage manufacturing team members to reach Cirtec's quality standards
Must be able to read blueprints and interpret technical specifications and illustrations
Strong computer skills associated with MS Office suite, Minitab, and SolidWorks a plus
The capacity to work well under pressure, change priorities on the fly, and take on new challenges
Project management skills and the ability to work to tight deadlines
Teamwork and people management skills
Experience associated with continuous improvement activities like participation in Kaizen events using lean manufacturing principles
A practical and logical approach to problem solving using lean six sigma concepts
Willingness to travel if required
Preferred
Previous experience with Class III Medical devices, FDA standards, ISO 13485 and GMP principles preferred
Benefits
Training and career development
Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid Time Off
401(k) retirement savings with a company match
Company
Cirtec Medical
Stellar Technologies is manufacturer of precision components and assemblies.
H1B Sponsorship
Cirtec Medical 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 (1)
2024 (1)
2023 (4)
2022 (2)
2021 (3)
2020 (8)
Funding
Current Stage
Late StageTotal Funding
unknown2016-08-01Acquired
Recent News
2025-10-02
2025-09-17
2025-08-29
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