What are the responsibilities and job description for the Program Manager / NPI Engineer position at Cinova Medical, Inc.?
Job Description
Job Description
Summary :
Act as Product Owner contributing to business outcomes and roadmap definition, defining product roadmap required to meet core business outcomes.
Collaborate with engineering groups to understand technical platforms and decisions that will deliver business value with an understanding of trade-offs
Monitor the progress of projects throughout their phases while mitigating future risks and acting tactically to resolve unforeseen issues
Track key project milestones, requirements, and deliverables to ensure all are completed within the timeframe established
Create, maintain, and support adherence to schedules
Gather information to make data driven decisions
The Project manager / Process Validation Engineer is responsible for defining validation strategy and executing / coordinating validation activities required to launch new Injection Molding products. automation assembly equipment or assembly process into the production environment. The successful candidate will help with validation activities that include Assembly Equipment Qualification, and Process Validation of an integrated manufacturing system. Work with a cross-functional team to introduce new manufacturing equipment, new processes, or new technology to mass production.
Responsibilities :
Generate and sustain Verification / Validation protocols / reports (IQ, OQ, PQ, PV) and related technical documents to support the transfer of assembly equipment / process from development into mass production.
Provide technical assessment and validation review / approval for changes regarding manufacturing equipment, assembly process and related standard operating procedures.
Participate in design, development, commissioning, and qualification of any NPI project.
Assist in failure investigations and root cause analyses occurred during equipment qualification and process validation.
Involve in the risk assessment (P-FMEA) of manufacturing equipment / process and provide input to the risk mitigation plan.
Involve in internal and external audits.
Qualifications :
Strong data analysis skills utilizing software such as Minitab.
Skilled in the use of Microsoft Office and IQMS.
Excellent verbal and written communication skills. Bilingual in English and Spanish preferred.
Experienced with equivalent test, process engineering, failure investigations, root cause analysis, measurement system analysis and automated assembly equipment is preferred.
Education / Experience :
Bachelor’s degree in mechanical engineering, Materials Engineering, Medical Device Engineering with mechanical emphasis, Electrical Engineering, automotive engineering, or related field.
Certificates and Licenses :
None
Supervisory Responsibilities :
Work Environment :
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to talk and hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and / or move up to 25 pounds. Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus.
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