Job description
Overview:
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.
Position Summary:
The Process Development Engineering group is responsible for developing and implementing test processes in manufacturing. 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. Create complex automated test fixtures with heavy focus on LabVIEW and/or TestStand development. Under the general direction of a functional manager, with moderate latitude for self-direction, operates in one or more areas of responsibility within a specific function. Responsibilities:
Education:
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
www.werfen.com
Werfen
Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company’s business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. 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.
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.
Position Summary:
The Process Development Engineering group is responsible for developing and implementing test processes in manufacturing. 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. Create complex automated test fixtures with heavy focus on LabVIEW and/or TestStand development. Under the general direction of a functional manager, with moderate latitude for self-direction, operates in one or more areas of responsibility within a specific function.
Key Accountabilities
Essential Functions:
- 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, if required by the function.
- Leads, designs and/or develops one or more of the following: new test methods, specifications, technical apparatus, software and processes for moderately complex components and functions.
- Identifies product defects and recognizes outliers in results. Can explain and document product defects and their impact.
- Effectively communicates complex technical information to a cross-functional team in the form of documentation, presentations or technical summaries.
- Provides technical guidance to and/or supervision of other group members and cross-functional technical teams. Able to mentor others.
- Provides technical support for or leads investigations in support of development and/or on-market activities.
- Independently generates predictable schedules for activities related to assigned projects.
- Leads and develops new test methods for manufacturing, including but not limited to:
- Defining specifications
- Designing & procuring fixtures
- Outsourcing fixtures and management of supplier deliverables
- Controlling hardware with LabVIEW and/or TestStand
- Automation and motion control
- Communicating with databases
- Optimizing processes conditions
- Executes process validations, including but not limited to: pFMECA, IQ, OQ, PQ, gauge R&R, DoE, process capability
Secondary Functions:
- May review and provide input to deliverables from other functions.
- Recommends and implements improvement initiatives to aid department practices.
Budget Managed: (if applicable)
- N/A
Internal Networking/Key Relationships
To be determined based on department needs, to include interactions such as:
- Will interface on a regular basis with groups across the organization as needed
Skills & Capabilities:
The ideal candidate for this position will exhibit the following skills and capabilities:
- Statistical Analysis, Root Cause Analysis, Creative Problem Solving, Critical Thinking
- Technically adept and confident
- Leadership: Accountability, Decision Making, Influence, Communication
- Mentoring
- Strong foundation in electrical engineering concepts
- Required: LabVIEW fluency, TestStand familiarity
- Desired: TestStand fluency, Process Validation experience, CAD design (Creo preferred), Python familiarity
Minimum Knowledge & Experience Required for the Position:
Education:
- Bachelor's degree in Engineering, Science or a related field
Experience:
- Eight years of product development or relevant experience
- Four to six 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 R
equirements:
- Some domestic and international travel may be required.
If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.
Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.
www.werfen.com
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