Sr Engineer Manufacturing

BP – Engineering        ·      Brooklyn Park, MN       ·        Full time

New hire sign on bonus of $2,250!

Job Summary

This position is primarily responsible for developing and implementing robust cost-effective manufacturing processes and methods in accordance with product specifications and Class III medical device quality standards.  This position recommends and implements improvements to sustained production processes, methods and controls; as well as coordinates the launch of new products into pilot production.

Essential Responsibilities

• Improves manufacturing processes, methods and controls for cost reduction, quality improvements and efficiency for both sustained and new products.
• Prepares engineering change orders and coordinates the deployment of changes including training operation team members.
• Improve manufacturing process instructions, product flow, assembly methods, space allocation, product quality and safety performance for both sustained and new products.
• Coordinates the manufacturing launch of new products including establishing yield targets, run rates, training needs and evaluating results.
• Develop and qualify various tools and equipment required for manufacturing processes.
• Performs product and process analysis for cost reduction, quality improvement and improved efficiency.
• Utilizing tools associated with risk management (e.g. PFMEA) to identify potential risks and the associated corrective actions.
• Supporting required equipment qualification and process validations (IQ, OQ and PQ).
• Troubleshoot manufacturing processes when defects occur.  Determine root cause and implement effective containment and countermeasures.
• Disposition non-conforming products and develop re-work procedures.
• Communicate with customers regarding process improvements and production changes.
• Represent manufacturing on cross functional teams.
• Lead Kaizen events and drive continuous improvement efforts.
• Provide new ideas for process improvements, design new fixtures and optimize automation process
• Take charge of the transfer of new products from R&D to commercial manufacturing
• Other duties as assigned.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications

• Bachelor’s degree in Engineering or related field
• Knowledge of manufacturing and assembly processes
• Excellent verbal and written communication skills
• Fluency in English
• Minimum 2-5 years of experience with Class II or III Medical devices, FDA standards, ISO 13485 and GMP principles.
• Leadership skills, including ability to organize, clarify and influence others
• Must be able to read blueprints and interpret technical specifications and illustrations.
• Association with supporting documents including, ECN’s, process deviation, non-conformances, stop shipment notifications and all associated quality related documents.
• Strong computer skills associated with MS Office suite, Minitab and SolidWorks a plus.
• Experience associated with continuous improvement activities, including participations and/or facilitating Kaizen events using lean manufacturing principles.
• The ability to understand a range of engineering functions and procedures.
• Interpersonal, presentation and communication skills.
• The capacity to work well under pressure and take on new challenges.
• Organizational and time management skills.
• Project management skills and the ability to work to tight deadlines

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls.  The employee is occasionally required to stand, and/or walk.  The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages.  The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Protective Clothing Required: None/PPE

Working Environment

Work is performed in an office and manufacturing environment.  The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

If you are an individual with disabilities who needs accommodation or you are having difficulty using our website to apply for employment, please contact one of the the locations below:

MN: Kim Dickey 763-493-8556 Ext. 55762 or Kim.Dickey@cirtecmed.com
CT: Cheryl Walker 860-814-3962 or Cheryl.Walker@cirtecmed.com
CA & AZ: Claire Buchanan 763-493-8556 Ext. 55702 or Claire.Buchanan@cirtecmed.com
MA: Melinda Polleck 978-703-6822 Ext. 66911 or Melinda.Polleck@cirtecmed.com

Please click here to apply.