Principal Manufacturing Engineer

SUMMARY: This position is responsible for the following areas: In-House and Contracted Manufacturing, Manufacturing Engineering, and Equipment Planning/Engineering in accordance the company’s Quality System and customer requirements. This position will ensure that assigned projects product/s are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing and, ultimately, scalability for 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.   Other duties may be assigned on an individual basis:

• As a technical individual contributor or team leader, oversee the construction of fixtures for new products or processes or current product enhancements.
• Manage in-house and contract manufacturing activities and relationships to ensure 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
• Develop manufacturing processes and Manufacturing Process Instructions (MPI’s) and lot history records (LHR’s) in collaboration with R&D and Quality
• Perform time studies for each manufacturing process and identify process development initiatives 
• Individually or through direct reports, ensure that all 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 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 products 
• Work with R&D staff to ensure smooth transition of 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 
• Train/Certify the MPI Trainer for manufacturing process instructions; may train other staff as needed 
• Work with Purchasing and Accounting to establish, monitor, and manage supply agreements. Maintain accurate cost data and work with accounting to update QAD to establish cost standards 

EDUCATION/EXPERIENCE:                                                                                                                                           

• BS or MS in Engineering or related discipline or equivalent experience in the medical device industry.
• 10 years increasingly responsible, relevant experience in the medical device 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
• Must be able to travel