Manufacturing Engineer I
At CONMED, our Manufacturing Engineering team comprises subject matter experts who strive to continuously improve the efficiency of our production lines, focusing on safety, quality, delivery, and cost effectiveness. The Manufacturing Engineers’ dedication and expertise ensure that CONMED products are 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 team. In this role, you will apply 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.
Responsibilities:
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 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 effectively communicate with site leadership
- 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
- 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 medical device products that improve patient outcomes, we invite you to apply for consideration!
Qualifications:
- Bachelor's degree in Mechanical, Manufacturing, or Automation Engineering, or a related field required
- Proficiency with SolidWorks CAD and analysis tools preferred
Benefits:
CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
- Competitive compensation
- Excellent healthcare including medical, dental, vision and prescription coverage
- Short & long term disability plus life insurance -- cost paid fully by CONMED
- Retirement Savings Plan (401K) -- company match dollar for dollar up to 7% Employee stock purchase plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.