Complete Onsite Contract Position: NPI / Validation Lead Engineer || Irving, TX
Rahul Kumar
Please share your interest and resume at ar...@centraprise.com
NPI / Validation Lead Engineer
Irving, TX
12+ Months Contract
Job Description:
Six to Eight (6-8) years minimum experience in engineering in a medical device environment preferred.
- Under the direction of the applicable Engineering Technical Leader, manages most aspects of multiple projects or initiatives.
- Role interfaces directly with other facility and corporate functional groups to ensure that goals and objectives are met within GMP/ISO compliance and product design changes are addressed appropriately.
- Lead multifunctional, cross departmental projects and initiatives geared towards achieving new process/product introductions (NPI), process improvements, cost reductions, and quality improvement.
Required Knowledge, Skills, Abilities, Certifications/Licenses And Affiliations.
- Advanced computer skills and use of software applications. Strong computer background (MS Office, MS Project Management, PowerPoint, Word, Excel, Outlook etc.)
- Experience in a manufacturing environment developing manufacturing standards.
- Proficient in project management, creating credibility within team members and expanding capabilities of the group.
- Experience or knowledge in short and long-term project management.
- Strong Organizational, interpersonal, oral and written communication skills.
- Ability to prioritize multiple commitments and technical problem-solving duties.
- Ability to shift priorities according to changes in department/facility needs and open to different ideas/approaches.
Duties & Responsibilities:
- Plans, documents, and executes new process development, designed experiments, validations, qualifications, testing, and design control deliverables in order to launch high-quality, compliant new products into manufacturing while meeting time, cost and margin targets.
- Monitors and supports new product processes until stabilized and fully transferred into production.
- Manages and executes projects and/or programs of moderate to high level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs are met.
- Provides project management guidance and business tools, utilizing a systematic approach to project execution. Prepares management reports and presentations. Effective project planning and structure.
- Develops creative strategies for the efficient completion of projects.
- Leads the optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost and capital investment management in an innovative manner.
- Challenges the “status quo” on a routine basis and develops new ideas within incoming processes.
- Coordinates phases of work with other departments including R&D, Operations, Regulatory Affairs, Sourcing, Process Excellence, etc.
- Technical support to Manufacturing Business Units for complex process issues, where higher level of technical expertise in a given field of knowledge is required.
- Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations.
- Revise and maintain engineering, equipment and process procedures.
- Coordinates communications and interfaces with end users, machine manufacturers and/or suppliers.
- Writes, develops and implements validation procedures.
- Reviews and analyzes data, understanding of statistics and the application of statistical data, able to determine normal and non-normal data along with probable causes of non-normal results
External Interactions:
- Required occasionally to interact with surgeons and/or key opinion leaders on site or on location.
- Required to interact with external suppliers to develop new materials, components or finished goods.
Regards,
Arjun | Account Manager
Centraprise Corp | 3 Ethel Rd, # 304 Edison, New Jersey – 08817
Email: ar...@centraprise.com
www.centraprise.com (E-Verify)
Please note - USC/Green Card candidates are always preferred on our positions…..
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