- Title: Process Engineer
- Code: RCI-9877645
- Location: South San Francisco California (CA) 94080
- Posted Date: 02/13/2020
- Duration: 18 Months
- Name:Shailesh Sargara
- Email: Shailesh.Sargara@rangam.com
- Phone: 908-704-8843 ✖ 219
The candidate has in depth experience in low to high volume manufacturing processes and methodologies and leads process development to support clinical and commercial production activities within device development programs, including internal engineering partners and external design/development partners and component suppliers.
The Senior Process / Manufacturing Engineer will be assigned responsibilities that will include OEM supplier interface, CMO/supplier interface to ensure translation of product requirements to automation and assembly processes, process and method development and validation oversite, and design transfer.
Quality Systems Compliance:
• Understand, implement and maintain Pharma Quality Policy and Pharma Quality System (PQS) in the department.
• Use (and create and implement, if necessary) local PTDU-D procedures and templates ensuring alignment with current versions of PQS documents and best practices.
• Assist with resolving issues arisen from internal quality assessments/audits, regulatory inspections and notified body interactions, and aid in driving closure of inspection issues by preparing appropriate responses and corrective action resolutions.
• Create and review discrepancy, change and risk management documents for PTDU-D and Devices Teams, as appropriate.
• Ensure compliance of training to PQS and job-related requirements.
• Draft, review and/or approve design control documents (i.e. DHF documents) to support device development deliverables using available templates, such as protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans, change management plans and design review meeting minutes.
• Employ good document practices (GDP) when recording data, maintaining archives and drafting and reviewing documents.
• Participate in hazards analyses and design assessments and reviews.
• Utilize electronic document archive system and collaborate with Document Control team to ensure document compliance with PQS standards and DHF regulations.
The incumbent in this position will be responsible for supporting activities within Device Development department and facilitating product development towards the goal of commercialization. This objective will be accomplished by executing activities in the areas of:
Process / Manufacturing Engineering:
• Understanding of GAMP concepts to facilitate a systematic translation of product requirements to new manufacturing equipment and manufacturing process outputs
• Understanding of injection molding tooling design, processes, and process capabilities to provide robust and repeatable components for assembly
• Proficiency with common medical device assembly processes that including insert molding, overmolding, micro-volume adhesive application, curing, and automated inspection in semi-automated and automated device assembly
• Oversite of process and test method development and validation activities at external suppliers
• Support design transfer activities
• Familiarity with clean room manufacturing processes that will facilitate manufacturing in a low particulate space
• Collaboration with internal and external suppliers at a detailed technical level with design engineers, equipment and production engineers.
• Provide engineering technical leadership to internal cross functional team and external development partners and component suppliers.
Education and Industry Experience
• B.S, M.S, or advanced degree in Engineering, with preference for Mechanical Engineering, or the equivalent.
Strong skills in relevant modeling and design tools, design controls and/or statistical analysis.
• Modeling: Monte Carlo Simulations, Tolerance Analysis, Finite Element Analysis.
• Device Design: CAD (Solidworks, AutoCad), Design for Manufacturability, Molding.
• Full data and statistical analysis (JMP, Minitab) and Design of Experiments, and providing detailed review of data with an emphasis on statistics.
• Design Controls for regulatory compliance & filing (ISO 13485, etc): GDP/GLP/GMP, Design History Files, protocols/reports, etc.
• Equipment development and qualification principles: URS, FAT, SAT, IQ, OQ, Trace Matrix
• Six Sigma (Green/Black Belt): DMAIC and DFSS
Up to 25% domestic travel may be required.