Sr Manufacturing Engineer - Exempt
Sr Manufacturing Engineer - Exempt
Posted on :
05-06-2025
Employer Active
1 Vacancy
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Job Description
Job Description:
- You will support multiple NV product lines at the Toledo site by leading and/or supporting process and cost optimization initiatives.
- The role focuses on equipment/process validation lean manufacturing and driving cross-functional project execution in a regulated medical device manufacturing environment.
- Design and optimize manufacturing processes layouts procedures and tooling.
- Lead equipment installation inspection and process validations (IQ/OQ/PQ.).
- Identify and drive continuous improvement initiatives (Lean Six Sigma.).
- Develop process control techniques and documentation.
- Collaborate with R&D Quality and Operations teams to support new product introductions and cost-reduction projects.
- Ensure compliance with FDA and international regulatory standards.
- Mentor junior engineers and lead project teams as needed.
- Bachelors degree with 4 years of relevant experience or a masters degree with 2 years of relevant experience.
- Medical device manufacturing experience.
- Hands-on with materials: Polymers (PEEK PTFE Nylon) and Metals (Stainless Steel Nitinol).
- Knowledge of bonding laser welding hydrophilic coating reflow plasma treatment.
- Experience in manufacturing line layout capacity analysis and design for manufacturability.
- Familiarity with FMEA risk management and statistical process control.
- Equipment and Process Validation.
- Project Management (leading cross-functional initiatives).
- Lean Six Sigma in a medical device production environment.
Employment Type
Full Time
Key Skills
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