Principal Manufacturing Engineer
This position is responsible for the following areas: Contract Manufacturing, Manufacturing Engineering, and Equipment Planning/Engineering in accordance with Truvic’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 from R&D to manufacturing and, ultimately, scalability for commercialization. This position may be an individual technical innovation contributor or, as needed, supervise a technical team with responsibility for mentorship and development of other manufacturing engineers.
Essential duties and responsibilities
Other duties may be assigned on an individual basis:
- Provide oversight and coordinate cross-functional operations project team activities from early project conceptualization through clinical testing.
- Manage contract manufacturing activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements.
- EnsureSupply 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.
- 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.
- As a technical individual contributor or team leader, oversee the construction of fixtures for new products or processes or current product enhancements.
- Work with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projects.
- 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 withQuality- 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.
- Establish manufacturing line and approve DCO’s for manufacturing engineering.
- Work with Purchasing andAccounting to establish, monitor, and manage supply agreements. Maintain accurate cost data and work with accounting to update QAD to establish cost standards.
- Using continuous improvement techniques, work with Quality Assurance to identify and implement programs to drive down cost and improve yield and reliability.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA and applicable regulatory regulations.
- Support the Quality System and Quality Policy. Be aware of Quality System procedures and requirements, including regulatory requirements and training requirements for position activities. Inform responsible personnel of concerns involving product quality.
- May be required to manage individual projects and deliver status reports
- Perform risk analysis activities and develop product testing plans and protocols; set up and run product testing and protocols in accordance with project plans
- Ensure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicableFDA, and Regulatory requirements.
- Actively promote and support the company’s Management Review process.
- Other duties as assigned
Education / experience
- BS or MS in Engineering or related discipline or equivalent experience in the medical device industry
- 8+years increasingly responsible, relevant experience in the medical device industry
- Knowledge of and experience in pilot/production line set up and validation in ControlledEnvironment
- Experience working under quality systems designed to meet governmental regulations such asFDA QSR, ISO 13485, the MDD, and knowledge of relevant standards
- Ability to detail project plans effectively
- Familiar with GMP, GDP procedures and requirements Ability to work as a team member and to be very flexible, adaptable, and to work under pressure
- Familiar with Design Control procedures and requirements
- Knowledge of and experience working within a Six Sigma and LEAN manufacturing environment
- 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
- May supervise more junior engineering or technician staff
* Work includes potential exposure to human blood borne pathogens or other potentially infectious materials.
* Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
* Work includes potential exposure to chemicals