- Leads customer projects, managing schedules and resources for successful project execution.
- Coordinates development activities internally and with customers to meet deadlines.
- Translates customer needs into engineering specifications and manufacturing processes.
- Ensures regulatory compliance with FDA, ISO, and other standards.
- Identifies materials, designs tooling, and optimizes production for volume, cost, and quality.
- Prepares engineering documents and oversees product testing/validation.
- Designs and validates manufacturing tooling, equipment, and processes.
- Maintains engineering documents and stays updated on industry trends and technologies.
- Assists sales in estimating materials and labor for quotations.
- Mentors new Product Engineers.
- Demonstrates company values of honesty, integrity, and respect.
- Performs other duties as assigned.
- Strong communication and teamwork skills.
- Proficiency in Microsoft Office, Solidworks, and related software.
- Experience with Lean Manufacturing/6 Sigma methodologies.
- Knowledge of injection molding, ultrasonic welding, or radio frequency welding.
- Familiarity with regulatory environments (FDA, FAA, ISO
- Preferred knowledge of medical device manufacturing and world-class manufacturing.
- 4+ years of related experience.
- Experience in regulated environments.
- Familiarity with production line layout and process validations.
- Bachelor's degree in Mechanical, Plastics, Biomechanics, or Biomedical Engineering.
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Medical Device Engineer - Buffalo, United States - CivicMinds, Inc
Description
Job: Sr. Medical Device Engineer
Location: Buffalo, NY (Direct Hire)
If you are interested in applying for this job, please make sure you meet the following requirements as listed below.
Job Summary: Plans, designs, and develops production processes for single-use medical devices, ensuring compliance with customer specifications and company procedures.
Job Duties:
Skills/Technical Skills:
Knowledge:
Experience:
Education:
