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- Lead and manage medical device projects from conception to completion, ensuring adherence to timelines, budgets, and quality standards.
- Collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to drive successful project outcomes.
- Develop and maintain project documentation, including design specifications, risk assessments, and project plans.
- Ensure compliance with industry standards, particularly ISO13485, and contribute to the continuous improvement of quality processes.
- Identify and mitigate risks, troubleshoot technical issues, and provide innovative solutions to challenges in the medical device manufacturing process.
- Bachelor's or Master's degree in a relevant engineering discipline (e.g., Mechanical Engineering, Biomedical Engineering).
- Proven experience in project engineering within the medical device industry, with a focus on manufacturing processes.
- In-depth knowledge of ISO13485 and other relevant quality standards.
- Strong problem-solving skills and the ability to work in a fast-paced, collaborative environment.
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
- Competitive salary commensurate with experience.
- Comprehensive health and dental benefits package.
- Opportunities for professional development and career advancement.
- A collaborative and innovative work environment.
