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Instrumentation Laboratory - Bedford Senior Engineer II in Bedford, Massachusetts

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:

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 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 complex in nature, in alignment with corporate goals.

  • Analyzes and interprets data, identifying trends and formulating the next steps, while effectively performing trade off analysis, 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 complex components and functions.

  • Identifies product defects and recognizes outliers in results. Able to explain and document product defects and their impact.

  • Effectively communicates technical information to a multidisciplinary team in the form of documentation, presentations and technical summaries and promotes collaboration.

  • Technical expertise in a least 1 area and emerging as a subject matter expert.

  • 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 CAPA or complaint investigations.

  • Independently generates predictable schedules for activities related to the function, understanding cross-functional dependencies.

Secondary Functions:

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

  • Recommends and leads implementation of improvement initiatives to aid department practices.

  • May be assigned CAPA ownership.

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 (if required by the function), Root Cause Analysis, Creative Problem Solving, Critical Thinking

  • Technically adept and confident

  • Leadership: Accountability, Decision Making, Influence, Communication

  • Mentoring

Minimum Knowledge & Experience Required for the Position:

  • Education:

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

  • Experience:

  • Ten years of product development or relevant experience

  • Six to eight 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.

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

Job ID: 2021-4469

Shift: 1st

External Company URL: https://werfen.com/en

Street: 180 Hartwell Road

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