Sr. Manufacturing Engineer I

- Senior

Boston, MA

Miscellaneous Manufacturing

About the position

The Senior Manufacturing Engineer I will work within the Integra Lifesciences CSS Operations Engineering organization to support the development, transfer to manufacturing, launch readiness and production stability requirements of existing products. This position will provide technical expertise and project management in the areas of medical device manufacturing process development and validation, DFM, COGs management, design transfer, production planning, and production stability.

Responsibilities

• Work in cross-functional project teams including R&D, Quality Assurance, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to develop and sustain surgical products for the neurosurgical medical device industry.
• Manufacturing process technical expert who can provide engineering knowledge and oversight to plan and develop manufacturing processes, identify, spec, and procure mfg equipment, develop operation plans to support product development and transfer, resolve manufacturing- and quality-related problems with products, and interface with production facilities to act as the 'Voice of Operations' on projects.
• Responsible for leading cross functional projects, including developing and executing project plans and milestone, controlling / adjusting project plans; developing alternate pathways or options; identifying and mitigating technical and project risks; presenting project status to management.
• Responsible for reviewing and updating applicable product specifications and drawings for legacy products. Responsible for identifying acceptance criteria for product specifications.
• Responsible for partnering with suppliers and internal manufacturing engineering teams to develop new processes and to review details of current manufacturing processes, review output of those processes, and make corrections where needed to improve robustness of output.
• Provide leadership on critical supplier related programs, to ensure stable supply and to support the overall supplier relationship.
• Responsible for managing corrective actions and the implementation of all corrective actions to ensure improvements are attained.
• Responsible for designing and implementing control plans and monitoring processes at internal and external manufacturing sites to ensure processes are controlled and stable.
• Utilizes time management techniques (e.g., prioritization, goal setting, scheduling, etc.) to better balance workload; identifies ways to enhance the way work is done to save time and enhance efficiency.
• Proactively manages priorities based on changing needs; adjusts priorities to minimize impact to other business needs; communicates priorities as appropriate.

Requirements

• Minimum of a bachelor's degree in mechanical, Manufacturing, Materials or Biomedical Engineering or equivalent is required.
• A minimum of 5 years applied experience with a B.S. and 3 years with a M.S. is required.
• Experience in the medical device industry is strongly preferred.
• Minimum of 3 years of Project Management experience is required, PMP certified preferred.
• A broad knowledge of manufacturing processes applicable to medical device manufacturing is required.
• Demonstration of a good knowledge of relevant products & surgical techniques is preferred.
• Design experience and knowledge of the full product life cycle is required.
• Good knowledge in the application and selection of medical grade materials and the ability to match manufacturing processes with specific technologies is strongly preferred.
• Proficient knowledge of Process Excellence / Six Sigma statistical analysis techniques and its application in manufacturing processes is strongly preferred.
• Knowledge of GD&T standards is strongly preferred.
• Knowledge of how to execute GMPs, ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications as related to medical devices is required.
• Strong technical communication skills and demonstrated ability to work independently with external suppliers is required.

Nice-to-haves

• Master's degree preferred.
• Demonstration of a good knowledge of relevant products & surgical techniques is preferred.
• Good knowledge in the application and selection of medical grade materials and the ability to match manufacturing processes with specific technologies is strongly preferred.
• Proficient knowledge of Process Excellence / Six Sigma statistical analysis techniques and its application in manufacturing processes is strongly preferred.
• Knowledge of GD&T standards is strongly preferred.

Benefits

• This position will require up to 10% travel.