Process Development Engineer II
About The Position
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Position Summary: Using company procedures, quality system requirements, and engineering best practices, performs process development, characterization, and validation activities in support of new product introduction (NPI) and platform-based initiatives. Independently plans and executes process characterization studies, process optimization efforts, and qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Analyzes process data to identify trends, assess process capability, and drive continuous improvement. Collaborates with cross-functional teams to support the development and implementation of new designs and platform technologies as identified by program leadership. Operates with a high degree of technical judgment and autonomy while ensuring compliance with applicable quality and regulatory requirements.
Requirements
- B.S. in Engineering and a minimum of 2 years experience related to the areas given above or suitable equivalent combination of education and experience.
Responsibilities
- Ability to perform validation activities, including but not limited to Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and evaluation of process operating conditions.
- Ability to perform validation activities, including but not limited to understanding risk documents such as pFMEAs.
- Performs varied engineering assignments under minimum of direct supervision and technical guidance.
- Technical responsibilities directed to engineering assignments which substantially add to the program.
- Designs and develops moderately complex parts, components, and/or circuits.
- Provides technical direction to support personnel as directed by engineering supervisor.
- Accomplishes independent designs, analyses, and interpretations of engineering data.
- May test materials for adherence to technical specifications.
- Prepares specifications for developed parts, components, and/or circuits.
- Maintains a good engineering notebook.
- Provides limited technical guidance to other engineers and supervision to technicians assigned to projects.
- Performs other duties as requested
Benefits
- medical, dental, and vision insurance
- 401k plan retirement benefits with an employer match
- paid vacation and sick leave
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
