Job Description

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:
Using Systems Engineering procedures standard to research and development, carries out assignments associated with research, design, or development, and the manufacturing of specific parts and 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 section or department. Demonstrates moderate to strong communication, leadership and management skill sets to transition into a lead technical or functional role.
Key Accountabilities:
+ Provides limited technical guidance and/or supervision of other group members and technical teams.
+ Communicates issues and project status to team leads and managers.
+ Prioritizes tasks in alignment with corporate goals and objectives, with minimal supervision.
+ Designs and develops new test methods or processes for moderately complex components and functions.
+ Provides suggestions for department improvements.
+ Plans and performs experiments and technical works with minimum technical guidance.
+ Effectively communicates technical information to a multidisciplinary team in the form of documentation, presentations and technical summaries.
+ Participates in and/or performs FMECA, FTA, traceability activities, requirements elicitation/review, integration testing, reliability activities, triage and verification activities across a given project.
+ Detects problems in routine procedures, investigates root cause and supports troubleshooting activities.
+ Able to identify product defects and outliers in results.
+ Participates in and/or provides technical input to technical reviews and evaluations.
+ Author's requirements, sub plans, risk management, protocols, reports, architecture, and configuration management documentation.
+ Adheres to all Systems Engineering and design control processes.

Budget managed (if applicable) N/A

Internal Networking/Key relationships:
+ Will interface on a regular basis with groups across the organization as needed

Skills & Capabilities:
+ Adapts to change quickly and is able to multi-task, managing several activities or projects simultaneously.
+ Demonstrates strong attention to detail, analytical, applied mathematics and problem solving skills
+ Demonstrates excellent written and verbal communication skills
Min Knowledge & Experience required for the position:
+ B.A. or B.S, with a minimum of 2 years of experience or equivalent combination of education and experience in Engineering, Science or related field, (Biology, Chemistry, Physics, Biotechnology, Biomedical, Electrical, Mechanical, Chemical Engineering).
+ In-vitro medical device experience highly desired.
+ Requires strong statistical knowledge and data interpretation skills in a highly technical medical instrument development environment.
+ Experience with the following tools/methods highly desired: Six Sigma, DOE, Failure Analysis, FMEA, Minitab, Lab View, MathCAD, MathLAB, Word, Power Point, Excel, DOORS.
+ Demonstrates knowledge of ISO 14971, ISO and FDA design control requirements

International Mobility: Required: yes

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.

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 specialities of Hemostasis, Acute Care Diagnostics and Autoimmunity. Our core business is dedicated to R&D, manufacturing and distribution
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