Apply on Employer Site

Cirtec Medical · 1 day ago

Sr. Manufacturing Engineer

Brooklyn Park, MN

Full-time

Onsite

Mid, Senior Level

$95K/yr - $127K/yr

5+ years exp

Cirtec Medical is a leading outsourcing partner for complex medical devices specializing in minimally invasive technologies. The Sr. Manufacturing Engineer is responsible for developing and implementing manufacturing processes to meet Class III medical device quality standards, while driving continuous improvement and efficiency in production.

ManufacturingMedical Device

No H1B

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

Attends, schedules, and leads project meetings to evaluate current and future process initiatives

Qualification

Manufacturing engineeringContinuous improvementLean six sigmaMechanical designFDA standardsISO 13485Project managementBlueprint readingMinitabSolidWorksTeamworkCommunication skillsProblem solving

Required

A Bachelor's degree in a STEM engineering required

At least 5 years of experience required in manufacturing engineering required

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

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