At CONMED, our Manufacturing Engineers work pro-actively with new product introduction teams and ongoing sustaining support initiatives to ensure the highest standards of production safety, quality, delivery and cost. The Manufacturing Engineers' dedication and expertise ensure that CONMED products continue to be accessible to health care customers around the world, ultimately improving patient outcomes.
We are seeking a self-driven and continuous improvement-focused Manufacturing Engineer to join our Utica, NY based Advanced Engineering organization. In this role, you will work alongside seasoned professionals through hands on application of engineering, project management and LEAN principles and methodologies. You will work with advanced manufacturing technologies, such as automation and robotics and will maintain ownership and accountability for KPIs for designated production lines.
Your efforts in problem solving, innovation and cross-functional collaboration will directly contribute to taking the site's safety, quality, delivery and cost metrics to the next level.
- New Product Introduction
- Participate in R&D activities as the manufacturing engineering representative providing guidance to the R&D Team on Design for Manufacturing (DFM)
- Oversee new product design transfer from R&D to manufacturing by driving day to day activities such as conducting research, data analysis and process development studies
- Author and/or review protocols and technical reports to support the Device Master Record (DMR) & Device History File (DHF)
- Lead the design, execution, analysis and study documentation to support new product launches
- Define and translate new product requirements into product designs and performance specifications
- Manufacturing Engineering and Sustaining Support
- Develop SOPs and manufacturing instructions and update existing documentation
- Conduct root cause analysis and lead CAPA investigations
- Resolve performance and/or quality issues post-launch for new product production
- Support the manufacturing operation as an independent engineer, leading investigations, validations, risk assessments, raw material evaluations, etc.
- Product Process Enhancements
- Drive test method improvements
- Design & implement automation technologies within manufacturing operations leading to overall quality & efficiency improvements
- Identify and drive cost reduction and overall product improvements such as yield and reliability
- Continuous Improvement Leadership and Project Management
- Collaborate with internal and external partners to achieve project objectives and deliver timely innovative solutions to meet business needs
- Identify technical and logistical obstacles to timely completion of project objectives and partner with management to identify and direct the appropriate resources to achieve solutions
- Drive continuous improvement activities utilizing Lean Tools and Methodologies
- Technical and Manufacturing Subject Matter Expertise
- Proactively develop and maintain technical knowledge in specialized areas, remaining up-to-date on current trends and best practices
- Evaluate innovative technologies and integrate them into manufacturing operations
- Ensure Good Manufacturing Practices (GMP) and all FDA and related regulatory requirements are applied and consistently met
- Create and implement verification and validation plans for systems and subsystems
- Create and execute characterization protocols and design of experiments
- Define problems and objectives, develop approach, analyze results and provide recommendations
- Incorporate appropriate statistical methods into experimental design and analysis
- Conduct design tests that will help to identify root cause on technical issues
- Perform process Failure Mode & Effect Analysis (pFMEA)
If you are focused on continuous improvement and passionate about the manufacture of products that improve patient outcomes, we invite you to apply for consideration!
A range of experience and education levels will be considered for this position. Title and compensation will be commensurate with experience. Minimum qualifications for include:
- Bachelor's degree in Mechanical, Manufacturing, or Automation Engineering, or a related field with a minimum of 3+ years professional work experience or;
- Master's degree with 1+ years professional work experience
- Proficiency with MS Excel, PowerPoint, and Word
- Experience utilizing Lean Six Sigma Methodologies and Tools
- Experience working in an FDA regulated environment and ISO 13485 preferred
- Proficient with SolidWorks CAD and analysis tools preferred
- Knowledge of system reliability management and analysis preferred