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.
Summary of Key Responsibilities:
- 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.
Required Qualifications and Skills:
- At least 10 years of experience in pharmaceutical industry with at least 5 years’ experience as Business Development Director or equivalent
- Bachelors of Science Degree or above
- Pharmaceutical product development and contract manufacturing experience is preferred
- Combined CRO and cGMP experience preferred.
- Demonstrated customer focus – a track record of building and maintaining positive customer relationships and key business outcomes
- Excellent organizational skills, with emphasis on strategic priorities and goal setting.
- Superior attention to detail as well as presentation and communication skills, both written and verbal.
- Technical skills required to understand and propose products or solutions by focusing on client requirements.
- Ability to communicate information, whether technical or non-technical to staff members and customers, in a clear and concise manner.
- Very proactive team player with a can-do attitude.
- Strong proficiency in Microsoft Word, Excel, PowerPoint, CRM and statistical analysis software.
- Ability to work within cross functional teams to fulfill customer needs and expectations
- Ability to multi-task and apply time management processes effectively
Budget managed (if applicable):
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 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.
Minimum Knowledge & Experience Required:
- 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.
- Not Required
- Some domestic and international travel may be required