Sil-Pro

Sil-Pro Medical Device Manufacturing Sil-Pro Medical Device Manufacturing
Job Openings >> Process Engineer/Sr Process Engineer
Process Engineer/Sr Process Engineer
Summary
Title:Process Engineer/Sr Process Engineer
ID:1521
Shift:First
Description
Sil-Pro's Engineers are vital to the success of our manufacturing operations and an essential part of providing outstanding results for our customers.  If you are committed to excellence and want to make a difference for yourself and in the lives of others, Sil-Pro may be your next home!
 
Job Summary: 
Follow good manufacturing practices (GMP) and principles to develop robust manufacturing processes

Essential Job Functions / Primary Responsibilities:
• Analyze new product specifications and translate these into manufacturing processes to establish production rates, achieve expected quality levels and establish reliability of finished product
• Develop and optimize polymer conversion process parameters for new tools
• Develop decoupled molding parameters to ensure process control
• Develop process parameters for secondary operations, including ultrasonic welding, bonding, and testing
• Manage data acquisition through part measurements using standard metrology tools
• Conduct data analysis and collaboration with Project Engineering and Quality Engineering
• Identify Operational Qualification (OQ) process parameters and Performance Qualification (PQ) settings
• Develop and document standard operating procedures (SOP) and product-specific operating procedures (PSOP)
• Train manufacturing personnel on SOPs and PSOPs
• Perform DOEs, develop pFMEAs, and participate in the development of control plans
• Organize internal cross-functional teams and corresponding outside vendors needed to meet project needs. Procure equipment as needed
• Use standard problem solving tools, e.g., 8D, 5 Whys, Fishbone.
• Apply effective inter-departmental communication and escalation
• Ownership of tooling and process from a manufacturability standpoint all the way from development to production release
• Investigation and corrective action ownership for any failed First Article Inspection or OQ/PQ failure

Other Responsibilities:
• Follow ISO 13485 and 21 CFR part 11 and part 820 and Sil-Pro Quality System protocols
• Collaborate with Manufacturing, Automation, Tool Room, and Quality Engineering in overall manufacturing process and equipment improvements

Education:
• Required 
- AA degree in Plastic Technology with related experience, BS degree in Plastic Engineering 
- Lean Sigma Green or Black Belt certification 
- Polymer Science, Lean Kaizen or other specialized background

Experience:
• Required
- 5+ years of experience in molded products with secondary operations
- Demonstrated leadership skills
- Successful problem solving
- Medical device manufacturing experience

Other Expectations, Skills and Abilities:
• Required
- Ability to challenge oneself to display consistent output by meeting all goals and deadlines
- Willingness to strive for excellence by producing work that is free of errors and mistakes
- Ability to demonstrate adequate job knowledge to deliver a world class performance
- Commitment to making improvements company-wide
- Ability to communicate clearly by conveying and receiving ideas, information and direction effectively
- Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
- Commitment to be present for all assigned shifts
- Flexible work schedule
- Use of statistical analysis software
- Interpersonal skills and good communication technique
- Ability to coordinate multiple projects and deadlines, manage and identify scope
- Act as a project leader on major projects
- Lean Manufacturing- Proficient in use of problem solving tools such as 5 why, Fishbone, 8D, etc.

Physical Requirements:  
While performing the duties of this job, employees are regularly required to sit, walk and stand; talk and hear, both in person and by telephone; use hands repetitively to finger, handle, feel or operate standard office equipment; reach with hands and arms; and lift up to 50 pounds.  50% mixture of sitting and standing, occasionally lift up to 50 pounds without assistance. Stand for periods of time up to 8 hours in a production cleanroom environment. 


This job description and related documents are intended to describe the general nature and level of work to be performed.  
This is not an exhaustive list of all duties and responsibilities.  Management reserves the right to amend and change the job description as necessary to meet business and organizational needs.

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