Manufacturing Engineer jobs in United States
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STERIS · 1 week ago

Manufacturing Engineer

STERIS is a leading provider of innovative healthcare and life science product and service solutions. The Manufacturing Engineer role involves providing engineering support to operations, improving manufacturing efficiency, and managing new product transfers while ensuring compliance with good manufacturing practices.

BiotechnologyHealth CareMedical Device
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H1B Sponsor Likelynote
Hiring Manager
Mina Ozturk
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Responsibilities

Provide general oversight and monitoring of machinery – including project coordination for maintenance, upgrades, and repair when needed
Help with troubleshooting of problems within the manufacturing process
Identify and implement GMP (good manufacturing practices) that apply to specific production area(s)
Provide training as needed to ensure that the production team understands and follows GMP
Lead/own CAPA (corrective and preventative actions) to resolve production and customer issues
Lead formal failure analysis and issue resolution activities to ensure preventative action is accomplished
Provide work direction to Product or Process technicians as required
Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g. qualifications, risk assessments, and work instructions)
Provide hands-on manufacturing equipment and process trouble shooting
Utilize project management skills to drive continuous improvement initiatives to optimize yield, quality, cycle time and/or ergonomics
Own and execute cost down initiatives on manufacturing lines
Initiate and lead lean transformations on manufacturing lines as well as within supporting areas
Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes, including troubleshooting of manufacturing issues when they occur
Provide operations department with effective technical support to meet manufacturing quality and quantity objectives
Assess and monitor manufacturing capacity capabilities and reconcile with demand. Propose capacity improvement recommendations accordingly
Specify tooling, fixtures and equipment required to meet manufacturing capacity requirements
Coordinate efforts associated with planning, procuring, installing and qualifying tooling, fixtures and equipment
Work with product development engineering to drive back lessons learned as new products are being developed
Evaluate and provide input to product development teams to help ensure the introduction of a capable and efficient operation
Create/evaluate and release process documentation for new processes
Specify tooling, fixtures and equipment required to meet manufacturing capacity requirements
Coordinate efforts associated with planning, procuring, installing and qualifying tooling, fixtures and equipment
Train operations personnel on new processes

Qualification

Manufacturing EngineeringLean Six SigmaISO 13485SolidWorks CADStatistical ToolsCAPATeam TrainingProblem SolvingProject Management

Required

BS in Engineering, preferably Electrical Engineering
Minimum of 3 years of related experience, required
Familiarity with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures
Experience in structured problem solving and use of statistical tools

Preferred

Experience in the medical device manufacturing industry
SolidWorks CAD experience
Training and experience in Lean and Six Sigma, or equivalent
Experience in Design for Manufacturing, DFMEA, PFMEA, DOE, and Validations

Benefits

Market Competitive pay
Extensive Paid Time Off and added Holidays
Excellent Healthcare, Dental and Vision benefits
Long- and Short-Term Disability coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits / discounts for programs such as Pet Insurance
Tuition Reimbursement and continuing education programs
Excellent opportunities for advancement in a stable long-term career

Company

STERIS is a leading provider of infection prevention and other procedural products and services, focused primarily on healthcare, pharmaceutical and medical device Customers.

H1B Sponsorship

STERIS 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 (26)
2024 (28)
2023 (15)
2022 (33)
2021 (18)
2020 (19)

Funding

Current Stage
Public Company
Total Funding
$0.28M
2010-05-21Post Ipo Debt· $0.28M
1998-12-01IPO

Leadership Team

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Daniel Carestio
President and CEO, STERIS
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Walter Rosebrough
CEO Emeritus & Senior Advisor
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Company data provided by crunchbase