| Job Description | 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.
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Job Purpose:
Develops and improves manufacturing processes by studying product and manufacturing methods.
Duties:
* Follow all personal and manufacturing Good Manufacturing Practices (GMP’s) as defined my ATEK’s practices, policies and Standard Operating Procedures (SOP’s) 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.
Knowledge/Education:
*Bachelor's Degree in Engineering
* Knowledge of FDAQSR, ISO13485, ISO14971, Risk Assessment
Job Experience:
* 5+ years engineering experience
* Experience in medical devices or other regulated industry preferred
Skills/Competencies:
* 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. |
| | Company | | ATEK Medical | Job Code | | State or Province | | Michigan | | |
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