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Kelly Science, Engineering, Technology & Telecom · 5 hours ago

Manufacturing Engineer

Madison, WI

Full-time

Onsite

Mid, Senior Level

$45/hr - $45/hr

4+ years exp

Kelly Science, Engineering, Technology & Telecom is hiring a Senior Manufacturing Engineer for a global medical device company located in Madison, WI. The Senior Manufacturing Engineer provides process engineering and controls support, ensuring projects adhere to good engineering practices while overseeing technical execution and compliance with regulations.

Staffing & Recruiting

No H1B

Responsibilities

Works closely with the R&D Engineers to transfer new designs from product development to manufacturing. Develops manufacturing processes and procedures by identifying and analyzing product specifications and quality standards; researching, designing, modifying, and testing manufacturing methods and equipment, and actively engaging and consulting with suppliers and vendors

Supports existing manufacturing processes and procedures by designing and executing research programs, applying knowledge of product design, fabrication, assembly, tooling, and materials, consulting with suppliers and vendors, and soliciting feedback from the Production team

Troubleshoot manufacturing issues and develop a plan to contain, correct, and put preventive/corrective actions in place to reduce the possibility of reoccurrence

Develops equipment, materials, and process performance requirements and performs vendor searches and equipment evaluation to ensure adequate capacity to produce quality products in required quantities at effective costs

Improves manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout

Designs comprehensive engineering activities to develop and implement effective, high-quality processes and design guidelines for dissemination

Develops and implements tools to automate data collection and analysis. This includes digitizing Device History Records and other manually collected data, as well as automating test equipment, and participating in ERP/Shop Floor implementation

Designs experiments and capability studies develops process specifications and designs and procures process tooling

Prepares product and process reports by collecting, analyzing, and summarizing information and trends

Maintains product and process database for quality and production data collected

Assures product and process quality by designing testing methods, testing finished products and process capabilities, establishing standards, and confirming manufacturing processes and procedures

Provides complex design reviews and feedback for improvements in manufacturability

Provides manufacturing decision-making information by calculating production, labor, and material costs, reviewing production schedules, and estimating future requirements

Provides manufacturing engineering information by answering questions and requests

Keeps equipment operational by coordinating maintenance and repair services, following manufacturer’s instructions and established procedures, and requesting special services as necessary

Completes design and development projects by training and guiding technicians

Develops process documentation and training materials for new processes, materials, and equipment

Analyzes new processes and equipment with the intent of achieving continuous improvement of present methods

Maintains product and company reputation by complying with government regulations. Provide support for ensuring, improving, and maintaining compliance with FDA and other related government regulations, company QMS requirements, and any other requirements defined by the company

Maintains professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies

Communicates and monitors process and material quality targets. Measures performance to targets and implements remedial actions as instructed

Contributes to team effort by accomplishing related results as needed

Responsible for communicating business-related issues or opportunities to the next management level

Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures

Performs other duties assigned as needed

Qualification

Medical device manufacturingProcess engineeringManufacturing process documentationMechanical manufacturing processesElectrical manufacturing processesProject managementLeadership skillsCommunication skillsTeamworkProblem-solving

Required

Bachelor's degree in Industrial, Mechanical, Electrical or Software Engineering or related area

Requires 4-10 Years of Work Experience with mechanical and electrical manufacturing processes, including assembly and testing

Experience in medical device manufacturing

Experience leading project teams or managing employees desired

Experience creating manufacturing process documentation such as work instructions

Strong leadership skills

Excellent verbal and written communication skills

Demonstrated ability to positively manage working relationships

Ability to work in small teams, as well as independently, with minimum supervision

Highly motivated, efficient, and enterprising with an inherent ability to drive tasks and projects to full completion

Benefits

Enhanced benefits (medical, dental, vision)

Paid Vacation

Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability

Retirement savings plan

Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year)

Transit spending account

Paid sick leave under the applicable state or local plan