Senior Manufacturing Engineer

Overview:

The product focus of will be on Class 2 and 3 medical device assemblies in the interventional space covering a range of therapies and technologies. This individual will manage process development and continuous improvement projects while transferring new products and processes from our multi-site Agile & LightSpeed Lab teams.

Responsibilities:

• Management of new and existing medical device programs. Responsibilities include maintaining development/ build schedules, customer technical interface, and working with Resonetics Business
• Development Managers and other Resonetics sites for coordinated production.
• Design and develop manufacturing processes, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety.
• Provide production line support including, but not limited to, implementing process improvements, troubleshooting equipment, training, and addressing operator inquiries. Generate and modify manufacturing process documentation and assure that documentation follow established policies and procedures per Resonetics established Quality Management System.
• Drive utilization of process improvement techniques to solve technical problems and make scale-appropriate equipment and process recommendations.
• Prepare engineering reports and communicate results to both internal (corporate) & external parties (customer).
• Drive process validation and documentation (IQ/OQ/PQ, TMV's, Manufacturing Processes, Equipment Commissioning, Preventive Maintenance, etc.).

Qualifications:

• (BS or MS) in Biomedical/Mechanical Engineering or relevant experience.
• Minimum of 6 years experience in a medical device manufacturing environment designing and manufacturing Class 2 or 3 finished medical devices.
• Proficient in NPI and PDP and establishing of practices. Demonstrated work ethic and understanding of deadline management.
• Demonstrated experience solving advanced technical problems using good engineering rigor and problem-solving discipline. Strong analytical skills with the ability to process operational or technical data and translate the output into a business result or opportunity.
• Strong statistical analysis skills (process capability, equivalence studies, regression, ANOVA, DOE).
• Proficient in SolidWorks (or equivalent) for tooling/fixture design. Well versed in GD&T and print generation.
• Training and/or experience in formal problem-solving techniques (A3, 6-Sigma, 5 Why's, DMAIC, etc.)
• Excellent writing skills, able to write detailed reports, comprehensive manufacturing procedures and validation reports/protocols.
• Ability to drive task clarity in a fast-paced environment with cross-functional stakeholders.
• Demonstrate project management, planning, and leadership skills.
• Strong communication skills, comfortable with leading and providing project status updates at the team, customer, and leaderships levels.