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Instrumentation Laboratory - Bedford Senior Engineer in Bedford, Massachusetts

Instrumentation Laboratory

Our Passion. Your Results.

Founded in 1959, Instrumentation Laboratory (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, patient blood management and Hemostasis testing. 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 medical professionals the most valuable and complete solutions to enhance patient care.

As an integral part of Werfen, a global healthcare company dedicated to delivering the highest quality in vitro diagnostic products, IL is supported by significant resources, outstanding scientific expertise and a tremendous knowledge base. IL is headquartered in Bedford, MA, USA.

Position Summary:

This Senior Engineer in the Process Development group is responsible for developing and implementing test processes for the manufacture of critical assemblies in medical diagnostic systems. Derive systems to collect and analyze electrochemical data. Create complex automated test fixtures, from conceptual design to hardware selection & integration as well as software control systems, documentation, and validation. Collaborate closely with both R&D and manufacturing across all phases of development. Independently evaluate, select, and apply standard engineering techniques, procedures, and criteria.

Key Accountabilities:

  • Acts as an individual contributor and core team or technical lead for a specific project

  • Leads and develops new test methods for intricate components, including but not limited to:

  • Defining specifications

  • Designing and procuring fixtures

  • Controlling fixtures with software

  • Optimizing processes conditions

  • Analyzes and interprets data, identifies trends, and formulates the next steps

  • Identifies and documents product defects, explains their impact, finds root cause, and implements effective mitigations

  • Effectively communicates complex technical information to a cross-functional team in the form of documentation, presentations, and technical summaries

  • Provides technical support for or leads investigations in support of development and/or on-market activities.

  • Authors documentation and participates in activities in support of design control

  • Executes process validations, including but not limited to: FMECA, IQ, OQ, PQ, gauge R&R, DoE, process capability

Secondary Functions:

  • May review and provide input to deliverables from other functions.

  • Independently generates predictable schedules for activities related to assigned projects.

  • Provides technical guidance to and/or supervision of other group members and cross-functional technical teams. Able to mentor others.

  • Recommends and implements improvement initiatives to aid department practices.

Budget Managed: (if applicable): N/A

Internal Networking/Key Relationships

  • Interface on a regular basis with groups across the organization as needed

  • May assist in engineering management for project-specific planning

Skills & Capabilities:

  • Expertise in test fixture development

  • Electrical engineering experience

  • General knowledge of statistics, including working knowledge of Minitab

  • Strong teamwork, organization, and communication skills

  • Desired: experience writing software to control hardware, especially Python or LabVIEW

  • Desired: process validation experience

Minimum Knowledge & Experience Required for the Position:

  • S. degree in Engineering or Science, Electrical Engineering preferred, with either:

  • Eight years of product development or relevant experience

  • Four to six years of product development or relevant experience for advanced degrees

  • Highly desired: medical device manufacturing background

  • Language: Proficiency in English language required

International Mobility:

  • Required: No

Travel requirements:

  • Some domestic and international travel may be required, 5% - 10% of the time

If you are interested in constantly learning and being challenged on a daily basis, we encourage you to submit your resume or CV.

Instrumentation Laboratory appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

Werfen is a global leader in in vitro diagnostics (IVD) in the specialties of Hemostasis, Acute Care Diagnostics and Autoimmunity. Our core business is dedicated to R&D, manufacturing and distribution of diagnostic systems for hospitals and clinical laboratories. Our other areas of expertise include Original Equipment Manufacturing, Clinical Software, Clinical Chemistry, Infusion Therapy, and Medical Devices and Scientific Instrumentation Distribution.

We operate directly in over 30 countries and in more than 100 territories through distributors. In 2016, our turnover was approximately 1.2 billion euros and we had an average workforce of 4,400 people. Currently, we are over 5,000 employees.

Job ID: 2021-3935

Shift: 1st

Street: 180 Hartwell Road