A top medical device company located in Maple Grove, MN is currently seeking a Senior Process Development Engineer to join their engineering team.
Job Summary: Engage in technology creation, evaluation, manufacture and process development associated with interventional medical devices. Provide direction to employees as assigned.
- Primary activities include the development of processes, equipment qualifications, process optimization, process validations, and fixture / equipment development.
- In addition to execution, responsibilities include managing and coordinating internal and external build / prototyping efforts.
- Research and select new technologies and/or materials for existing and new processes.
- Serve as liaison on specific projects between functional departments.
Education, Experience and Other Skills
- Requires a B.S. in Engineering or equivalent experience with a minimum of eight years of engineering, including five years of medical device product development (ISO/QSR).
- Strong engineering and technical skills are required including: statistical analysis, process capability analysis, test and instrumentation. Strong design and scientific methodology is desired as well as excellent mechanical and problem solving abilities
- Must have good computer skills that include project management and standard computer applications (word processing, database management, spreadsheets, etc). (Experience with CAD applications (AutoCAD, SolidWorks or ProEngineer) preferred.)
- Medical device development experience covering the range from product conception through manufacturing transfer and commercialization.
- Experience with subsequent product support is valuable.
- Knowledge of regulatory requirements, physiology and medical/clinical practices is also beneficial. Knowledge of FDA, ISO guidelines and compliance requirements are necessary.
- The selected individual should have experience with test method development and validation.
- Possess good aptitude for creative thinking within a multi-disciplinary team.
- Effective interpersonal, oral and written communications skills with demonstrated ability to function independently and effectively.
- This individual will interact with outside vendors and may interact with physicians.
Interview process for this position would involve telephone call with hiring manager and a final on site interview. If this is something that is interesting to you please send your resume.
Sthree US is acting as an Employment Agency in relation to this vacancy.