Process Development Engineer III

Werfen North America; Bedford (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in specialized diagnostics seeks a Process Development Engineer III to oversee new product development. The successful candidate will lead design transfer processes, validate manufacturing approaches, and communicate effectively within cross-functional teams, driving innovation and quality in medical diagnostics.

Qualifications

• Five years of product development or relevant experience.
• One to three years of product development for advanced degrees.
• In vitro medical device experience highly desired.

Responsibilities

• Lead Process Development Engineer for new product development.
• Accountable for completion of assigned deliverables.
• Analyze data, identify trends, and create documentation.

Skills

Statistical analysis

Root cause analysis

Creative problem solving

Technical leadership

Strong teamwork

Strong communication skills

Education

Bachelor's degree in Engineering, Science or a related field

Tools

CAD design (Creo preferred)

Job description

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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.

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 product s, which perform viscoelastic testing on whole blood . Process Development Engineer ing 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 manag ing supplier deliverables
• Creating, documenting, and executing tests
• Mapping process limits and capabilities
• Advise on Design for M anufacturability, A ssembly, T est (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, G R&R /MSA, process SW validations, spreadsheet validations
• A naly ze risks : design change risk assessments, pFME A/ 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 ), M anufacturing , O perations
• 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
• D etailed 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Engineering and Information Technology

• Industries

  Medical Equipment Manufacturing

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