Senior Systems Engineer
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.
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 a department manager, with moderate latitude for self-direction, operates in one or more areas of responsibility within a specific section or department. Demonstration of strong development, leadership, and management skills will allow transition into a lead technical or functional role.
- Leads and manages the Risk Management File for Blood Gas Systems
- Leads FMECA, FTA, traceability activities, requirements refinement activities across Blood Gas Systems.
- Provides technical support for Operations and Service department's requests for Systems Engineering Support.
- Provides input to schedule for Systems Engineering activities related to assigned projects.
- Provides input to metrics for each project within the program to monitor development time to aid in the creation of predictable schedules.
- Independently prioritizes tasks in alignment with corporate goals and objectives.
- Recommends new tools to optimize processes, procedures and test methods.
- Plans, performs and coordinates technical work with minimal supervision.
- Leads and/or supports root cause investigations in support of on-market complaints.
- Able to identify product defects and outliers in results.
- Participates in and/or challenges designs, tolerance studies, change requests, procedures, test methods, protocols and reports and assists in resolution of conflicting design requirements.
- Authors and/or reviews project sub-plans, requirements, risk management.
- Provides technical support for CAPA investigations.
- Adheres to 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
- Adapts to change quickly and is able to multi-task, managing several activities or projects simultaneously.
- Demonstrates proficiency in performing root cause analysis and initiating and leading troubleshooting activities.
- Demonstrates strong development, management and leadership skills with the ability to think independently.
- Demonstrates technical confidence to interact with engineers of other disciplines, supports technical discussions, and demonstrates the ability to make technical decisions
- Ability to produce quality written work, such as, technical reports, protocol and plans.
- Ability to skillfully present work and communicate ideas effectively to a multi-disciplinary teams.
- Ability to understand complex system interactions and the effect on analytical performance.
Min Knowledge & Experience required for the position:
- B.A./B.S. with a minimum 8 years of experience or M.S. with 6 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.
- Demonstrates strong knowledge of ISO 14971, ISO and FDA design control requirements
- Experience with the following tools/methods higher desired: Six Sigma, DOE, Failure Analysis, FMEA, Minitab, Lab View, MathCAD, MathLAB, Word, Power Point, Excel, IBM DOORS.
- Knowledge of Systems Engineering theories and practices with the ability to effectively incorporate these practices.
- Some domestic and international travel may be required
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 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.
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