Sr. Systems Engineer

Department: Research & Development

Location: US-California-San Jose

Compensation: $149,900 - $206,100 / year

Description

This position is ideal for innovative professionals to join the Systems Engineering team as a Sr. Systems Engineer, guiding the design control processes of Align’s products. Partnering with cross-functional teams, you’ll provide technical expertise, documentation, direction, and support to plan and execute projects focusing on new product development and improving existing products. This role is vital in shaping Align Technology’s product development and regulatory compliance.

Role expectations

• 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).
  
  

What We're Looking For

• 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.
  
  

Complementary Skills

• Engineering experience and Technical Writing desired.
  
  

Applicant Privacy Policies

Review our Applicant Privacy Policies for additional information.

Global Diversity Statement

At Align, we believe in the power of a smile, and we know that every smile is as unique as our employees. As we grow, we are committed to building a workforce rich in diverse cultural backgrounds and life experiences, fostering a culture of open-mindedness and compassion. We live our company values by promoting healthy people and healthy communities, all with the intent of changing millions of lives, one unique smile at a time.

Equal Opportunity Statement

Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.