Location: Colorado Springs CO
Duration: 6 Months+
Responsible for Process validation and verification work to complete legacy product process validation remediation. Knowledge of Master Validation Plans, IQ, OQ, PQ, PPQ, equipment Software validation, test method validation, gauge R&R, and a clear understanding of FDA’s QSR and cGMP, and a good grounding in statistics would be instrumental to success
Carrying out assignments in a safe and efficient manner. All work should maintain a focus on safety and ergonomics and be in accordance with all established safety codes, polices and government guidelines.
Able to dig deep for root cause, analyze objectively, draw logical conclusions and follow through quickly to deliver solutions. A successful candidate has a positive mental attitude and can interact with ease within and outside our team to develop and deliver win-win solutions.
Demonstrating competency in design and use of engineering systems and tools. Being proficient in CAD is expected (SolidWorks preferred). Complex modeling may be required.
Developing and designing process monitoring systems to control and verify process requirements
Contributing to an environment in which all team members are respected regardless of their individual differences and are motivated to improve both their individual and team contributions to achieve desired business results. Training less experienced personnel on established methods and procedures. Facilitating the transfer of technical knowledge, while demonstrating an understanding of those with a diverse background or experience.
Communicating fully with teammates and others who have a need to know. Being informative without being obtrusive or vexatious. Communicating in a way that is timely, yet prompt; complete, yet concise; candid, yet accurate; and clear, yet responsive.
Effectively prioritize work across multiple tasks to meet deadlines and team commitments.
Maintain accurate lab notes in accordance with Good Lab Practices.
Produce high quality, comprehensive written documentation to support audit readiness. All documentation must tell a complete, easy to follow story as a stand alone document for unfamiliar reviewers.
Job Related Skills:
Advanced knowledge of job related tools, processes, testing equipment, and catheter production equipment preferred. Demonstrated history of fast learning for job related tools, processes, equipment required
Proficient in Word, Excel, Outlook, Solidworks, JMP statistical software, Agile documentation management system, Maintenance Connection, and all other job related computer programs
Detail oriented, well organized, strong verbal and written communication skills
Self-motivated and creative
Technical and mechanical skill and knowledge
Typical experience required is 8+ years as an Engineer in a related field
Four-year degree required, preferably in Engineering; advanced degree is preferred (MS or MBA)
Statistical analysis skill set is required. Experience with JMP software is a plus.
A thorough understanding of process validation relating to medical device regulations is preferred
A demonstrated ability to plan and run multiple projects is highly desired
Knowledge of Process Validation, IQ, OQ, PQ, PPQ, Software validation, test method validation, gage R&R, and a clear understanding of FDA’s QSR and cGMP
Design Controls experience is required
Medical device experience is highly recommended, with experience in a regulated industry required
Familiarity with the Agile Project Management Scrum methodology a plus