Process Development Engineer III

Werfen

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 7000 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. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Position Summary:

Using Engineering procedures standard for research and development carries out assignments associated with research design development support or manufacturing of specific parts processes software or components of medical diagnostic systems. Independently evaluates selects and applies standard engineering techniques procedures and criteria using judgment in making minor adaptations and modifications. Under the general direction of senior engineering personnel with moderate latitude for self-direction operates in one or more areas of responsibility within a specific Function.

This role will be the lead Process Development Engineer for new product development on the ROTEM delta and sigma products which perform viscoelastic testing on whole blood. Process Development Engineering is the functional group within R&D Hardware Engineering that is responsible for design transfer (developing and implementing assembly and test processes in manufacturing). Major areas of focus are standard operating procedures process validation risk analysis fixture design and process optimization.

Key Accountabilities

• Acts as an individual contributor core team or technical lead for a specific project.
• Accountable for the completion of assigned deliverables in accordance with approved schedules.
• Authors documentation and participates in activities in support of design control
• Independently plans performs & prioritizes tasks that are moderately complex in nature in alignment with corporate goals.
• Analyzes and interprets data identifying trends and formulating the next steps.
• Leads and develops processes for manufacturing including but not limited to:
  • Defining requirements for fixtures and processes
  • Outsourcing fixtures and managing supplier deliverables
  • Creating documenting and executing tests
  • Mapping process limits and capabilities
  • Advise on Design for Manufacturability Assembly Test (DFM DFA DFT)
  • Create and modify standard operating procedures (SOPs)
  • Identifies product defects and recognizes outliers in results. Can explain and document product defects and their impact.
• Executes process validations including but not limited to: IQ OQ PQ GR&R/MSA process SW validations spreadsheet validations
• Analyze risks: design change risk assessments pFMEA/pFMECA
• Effectively communicates complex technical information to a cross-functional team in the form of documentation presentations or technical summaries.
• Provides technical support for and/or leads investigations in support of development and/or on-market activities.
• Generates predictable schedules for activities related to assigned projects.

Secondary Functions:

• May provide limited technical guidance and/or supervision of other group members.
• Recommends improvement initiatives to aid department practices.

Budget Managed (if applicable)

• N/A

Internal Networking/Key Relationships

• Highly cross-functional: regular interface with other groups within R&D (Hardware Analytical Project Management SW) Manufacturing Operations
• Assist with R&D management for project-specific planning

Skills & Capabilities:

• Statistical analysis root cause analysiscreative problem solving
• Technical expertise in at least 1 area
• Technical leadership: accountability decisionmaking influence
• Strong teamwork organization and communication skills
• Detailed documentation
• Desired: CAD design (Creo preferred) optics knowledge hardware integration with SW/firmware

Minimum Knowledge & Experience Required for the Position:

Education:

• Bachelors degree in Engineering Science or a related field

Experience:

• Five years of product development or relevant experience
• One to three years of product development or relevant experience for advanced degrees
• For internal candidate promotion: Demonstrated proficiency in meeting all competencies of current level and acceptable performance history may be used in lieu of experience
• In vitro medical device experience highly desired.

Additional Skills/Knowledge:

• Language: Proficiency in English language required

International Mobility:

• Required: No

Travel Requirements:

• Some domestic and international travel may be required.