Manufacturing Engineer

Overview

Direct hire position with pay range of $150,000 to $170,000

Location:

Campbell, CA

• 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.
• 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…