Senior Manufacturing Engineer
Senior Manufacturing Engineer
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$ 88000 - 105000
1 Vacancy
Job Description
Overview
Resonetics is a global leader in advanced engineering prototyping product development and micro manufacturing driving innovation in the medical device industry. With rapid expansion across all our locations we continue to push the boundaries of technology while fostering a dynamic employeecentered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micromanufacturing and being part of something bigger
The Senior Manufacturing Engineer will be responsible for managing the production development and readiness activities for finished medical devices and catheter subassemblies. This individual will act as a NPI core team member representing the interests of manufacturing engineering and operations. 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 multisite Agile & LightSpeed Lab teams.
Join Resonetics and be part of a team thats redefining medical device manufacturing. If youre passionate about innovation and thrive in a fastpaced environment wed love to hear from you.
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 scaleappropriate 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 TMVs Manufacturing Processes Equipment Commissioning Preventive Maintenance etc.).
Required 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 problemsolving 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 problemsolving techniques (A3 6Sigma 5 Whys DMAIC etc.)
- Excellent writing skills able to write detailed reports comprehensive manufacturing procedures and validation reports/protocols.
- Ability to drive task clarity in a fastpaced environment with crossfunctional 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.
Preferred Qualifications
- MS in applicable Science or Engineering field.
- Demonstrated experience interventional device design assembly packaging & sterilization.
- Experience as a multidiscipline core team lead for a finished medical device.
- Certification or training in Lean Six Sigma methodology.
- ISO 13485 (Medical Devices
- Quality Management Systems). Project Management Professional (PMP).
Compensation
Thecompensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $
Required Experience:
Senior IC
Employment Type
Full-Time
