Process Development Engineer III, Boston

Overview:
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 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 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.

Responsibilities:

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 

Qualifications:

Minimum Knowledge & Experience Required for the Position:

Education:

Bachelor's 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.