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Manufacturing Engineer Consultant I - 3 Positions
6 months
Carlsbad, CA
Highly Desired Skills:
FDA Regulated environment experience.
Ventilation experience.
Change order processing experience.
Continuous improvement
projects at the department level. Represents Operations in
multi-disciplinary teams. Introduces new products from Development to
Operations. Specifies requirements from Operations.
Experience: Minimum 8 years professional experience in the
applicable role.
Education: Bachelor's /Master's degree in Engineering.
Demonstrated capability and experience in role.
Expert on manufacturing process flow and design transfer, Lead
manufacturing fixture development, process development and
qualifications, lead process development and optimization of critical
fabrication, maintain manufacturing specifications, requirements, and
Failure Modes and Effects Analyses (FMEA) in accordance with protocols
and FDA guidance documents, expert technical lead on design transfer in
partnership with contract manufacturers, conduct and lead failure
investigations, ensure document management and manufacturing control
compliance.
conduct and manage structured design reviews. works with hardware,
software and firmware engineers, user experience specialists and system
engineers, guide and participate in test method validation, risk
assessment, requirement development, protocol and validation report
writing.
Maintain, Validate and Release Test Systems in Production Environment,
ideally in FDA regulated business.
Firm understanding of IQ, OQ, PQ and Software Validation requirements
and practices.
Expertise in PFMEA, Gage R&R, test system and manufacturing software
validation for medical devices within manufacturing environment.
Ability to learn and adapt to client's QMS and work closely with
Client's
Engineering community on new validation methods and re-validation
projects. Guide and participate in bug testing, identification, and
problem solving.
Contact information:
Depensee
Maddala
APN Software Services Inc
39899 Balentine Dr, Suite 385
Newark, CA 94560
Phone: 510-683-9043 Ext:152
Fax: 510-623-5055
Email: depensee@apninc.com
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