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AlignTech Sr Systems Engineer United States, California, San Jose 894460221
30.03.2025
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- Research & Development
- Employment Type
- Full Time
- US-California-San Jose
- Workplace type
- $149,900 - $206,100 / year
- Reporting To
- Planning and executing projects that focus on new product development and improving existing products.
- Providing hands-on technical support and working closely with other engineering groups to solve a variety of technical challenges.
- Supporting product development with a heavy focus on the design control of medical device processes, testing, and documentation.
- Support validation and usability studies of medical devices and software.
- Conduct PFMEA analysis across products, document and present findings to senior management and cross functional teams
- Ensure accurate creation, documentation, and implementation of manufacturing requirements and work instructions and related QMS documentation and activities.
- Writing, editing, reviewing, and finalizing technical documents required for regulatory submissions of medical device products.
- Monitor our Startup Line manufacturing processes to ensure compliance with regulatory requirements and product specifications identifying and implementing improvements.
- Ensuring compliance with US and European medical device documentation regulatory requirements (21 CFR Part 820, ISO 13485).
- Knowledge of testing and documentation for pre-submissions, verification, and validation protocols and reports.
- Experience working with cross-functional development teams to ensure successful project outcomes.
- Strong understanding of regulatory requirements for medical devices in the US and Europe.
- Excellent communication skills.
- BS/MS/Ph. D. in an engineering discipline
- 8+ years of experience in the medical device/pharmaceutical industry, familiar with medical device regulations and product development for medical devices.
- Engineering experience and Technical Writing desired.
Your growth and well-being:
- Health and well-being programs to keep you thriving in both body and mind.
- Employee discounts on Invisalign products.
- Learning opportunities though online learning resources and support for your individual development plans.
- Inclusive workspace that fosters diversity and collaboration.
Country-specific details will be shared with you by your recruiter during the interview process.
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