|About the Job
Due to double digit growth, ATEK Medical, a West Michigan manufacturer of medical devices, is hiring experienced Manufacturing Engineers.
Candidates must have experience supporting a manufacturing environment, creating/writing technical documents (engineering specs, operator work instructions, etc), and Lean/Six Sigma.
Our ideal candidate will have previous experience in a manufacturing environment in the medical device or pharmaceutical industries. We are willing to consider candidates who have worked in other highly regulated environments.
Develops and improves manufacturing processes by studying product and manufacturing methods.
* Follow all personal and manufacturing Good Manufacturing Practices (GMPís) as defined my ATEKís practices, policies and Standard Operating Procedures (SOPís) to insure that FDA regulations are met.
* Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; and soliciting observations from operators.
* Supports the Value Stream sustaining engineering and new product launch activities.
* Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.
* Improves manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.
* Assures product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes.
* Provides manufacturing decision-making information by calculating production, labor, and material costs; reviewing production schedules; estimating future requirements.
* Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
* Maintains product and company reputation by complying with government regulations.
* Keeps equipment operational by coordinating maintenance and repair services by following manufacturer's instructions and established procedures and requesting special service when needed.
*Bachelor's Degree in Engineering
* Knowledge of FDAQSR, ISO13485, ISO14971, Risk Assessment
* 5+ years engineering experience
* Experience in medical devices or other regulated industry preferred
* Dealing with Complexity
* Manufacturing Methods and Procedures
* Proficiency in AutoCad and Pro Engineer
* Good knowledge of statistical tools
* Excellent presentation skills
* Flexible and adaptable to manage multiple projects and priorities
* Error free documentation and technical writing skills
Please apply via our careers website.
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