What are the responsibilities and job description for the Engineering Project Lead position at COLTENE USA?
As a Product Engineer at Coltene, you will be responsible for driving innovation and developing high-quality products.
Responsibilities
- Develop and execute comprehensive testing plans, ensuring compliance with regulatory requirements.
- Collaborate with internal and external manufacturers to resolve product design, quality, and manufacturing-related issues.
- Create and maintain detailed drawings and specification documents for new product designs.
- Assist Marketing and Regulatory teams in developing product labeling and literature by interpreting technical data and product performance.
Qualifications:
- Familiarity with medical device standards (ISO 13485, IEC 60601-1, ISO 10993, 21 CFR Part 820, etc.).
- Proficient in 2D/3D CAD design software (Autodesk Inventor preferred).
- Excellent communication and interpersonal skills.
