Med Device Manufacturing Engineer; Consumables

Position: Med Device Manufacturing Engineer (Consumables)
Manufacturing Engineer
Direct hire position with pay range of $150,000 to $170,000

Location:

Campbell, CA

Background and experience:

" BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
" Knowledge of and experience in pilot/production line set up and validation in Controlled Environment.
" Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, the MDD, and knowledge of relevant standards.
" Ability to detail project plans effectively.
" Familiar with GMP, GDP procedures and requirements.
" Familiar with Design Control procedures and requirements.
" Excellent communications skills (both written and verbal) required.
" Ability to work independently or in team setting required.
" Project management experience preferred.
" Working knowledge of quality system requirements and compliance (e.g. traceability, QSRs, ISO, MDD/MDR requirements) and other applicable regulations.
" Experience working with ERP/MRP/Documentation control systems
" Understanding of contracts (supply, services, non-disclosures agreements, etc.).Skilled in the use of Microsoft office suite, especially Word, PowerPoint, Excel
" Previous exp. in medical device company with experience and emphasis on single use devices and consumables highly preferred
" Excellent communications skills (both written and verbal) required
" Ability to work independently and to prioritize activities and workload
" As a technical individual contributor or team leader, oversee the builds for single use device and consumable products
" Manage in-house and contract manufacturing activities and relationships to ensure single use device and consumable products are manufactured in accordance with product plans and quality/regulatory requirements.
" Ensure Supply Chain is aware of inventory, raw materials, and component requirements per the planned build schedule; manage and be accountable for material issued to production or engineering projects.
" Conceptualize and implement manufacturing improvements, tooling, and systems to increase productivity and/or improve yields.
" Define manufacturing or process related technologies to reduce manual operations and/or improve repeatability.
" Participate the selection of suppliers for manufacturing components.
" Work closely with Quality to create manufacturing and process related SOPs and Wis.
" Develop manufacturing processes and Manufacturing Process Instructions (MPI s) and lot history records (LHR s) or Device History record (DHR s) in collaboration with R&D and Quality.
" Perform time studies for each manufacturing process and identify process development initiatives.
" Ensure that all single use device and consumable products are manufactured in compliance with the company Quality System, customer needs, budgetary requirements, schedule requirements, and the regulatory requirements.
" Work with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projects.
" Provide oversight and coordinate cross-functional operations project team activities from early project conceptualization through clinical testing.
" Create, maintain, and manage manufacturing tasks of project schedule, and ensure that critical timelines and/or budgets are established and met.
" Participate in manufacturing team meetings to ensure adequate communication between members and develop positive, proactive working relationships with other staff.
" Develop manufacturing specifications for single use device and consumable products; coordinate all process validation activities with Quality- IQ/OQ/PQ.
" Determine tooling, equipment, and fixture needs for the timely and cost-effective manufacture of single use device and consumable products.
" Define requirements to ensure smooth transition of single use device and consumable products into manufacturing while assuring manufacturability, achieving cost targets and conformance with regulatory and quality requirements.
" Work with suppliers to ensure parts/services are properly documented and meet specifications.
" Manage specifications for sub and final assemblies; identify tooling requirements design/document/procure/verify tooling.
" Establish manufacturing line and approve DCO s for manufacturing engineering.
" Define critical process outputs and ensure that MPIs and training methods confirm the outputs.
" Using continuous improvement techniques, work with Quality Assurance to identify and implement programs to drive down cost and improve yield and reliability.
" Plan equipment and workflow layouts in manufacturing areas. Manage manufacturing equipment design and development to ensure that equipment is cost-effective and meets manufacturing specifications and maintain and coordinate all calibration and preventive maintenance…