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Process Development Engineer

Posted by: Ativa Medical

Posted date: Dec-17-2015

Location: St. Paul, MN

Process Development Engineer Position
Position Summary:

 

We are seeking an experienced process development engineer who has worked in high volume disposable manufacturing in a regulated environment.  This position will collaborate with design, quality and manufacturing to transition new products from development to full scale manufacturing. Key responsibilities include characterizing and identifying key process variables and design variables to ensure a low cost robust manufacturing process.   Additional duties will include participation in risk assessment activities of the manufacturing process and identifying mitigation solutions as needed.

 

 

Primary Duties and Responsibilities:

  • Proficient knowledge and use of applicable industry standards
  • Experience with scientific manufacturing principles and lean manufacturing principles
  • Analytical and creative thinking skills. 
  • Technical writing of clear and detailed, procedures, test protocols and reports.
  • Analyzing test data using standard statistical techniques.
  • Develop and implement  cost reduction strategies for disposable manufacturing
  • Explore and identify possible manufacturing processes test methods for disposable manufacturing
  • Participate in process validation activities

 

 

 

Qualifications (Knowledge, Skills & Abilities)

·         Strong knowledge with industry standards (including ISO 13485 & 14971, FDA QSR)

·         BS in Mechanical Engineering or a related field

·         Analytical and creative thinker with experience with statistical methods

·         Effective oral and written communication skills

·         Demonstrated organizational and administrative skills.

·         Ability to prioritize and handle multiple tasks.

·         Demonstrated problem-solving skills

·         Experience with polymers and adhesives

 

Preferred

·         5 - 7 years’ experience as a process development engineer in an IVD medical device environment

 

 

Job Title Process Development Engineer
Post Details
Email careers(at)ativamed.com
Employer's Website www.ativamed.com
Category
Job Discipline Job Discipline -> Biotech
Job Classification Job Classification -> Engineering
Job Type Job Type -> Full-time
Location St. Paul, MN
Key Words Manufacturing, Process Development
Start Date January 18, 2016
Deadline