Startup line Engineer

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Department: Research & Development
Location: San Jose, CA
Compensation: $103,000 - $141,700 per year

Join our Research and Development team as a 3D Printed Medical Device Startup Line Engineer with a focus on manufacturability of medical devices. In this role, you will collaborate with a small team to produce custom medical devices using cutting‑edge 3D‑printing technology, develop, manufacture, and transfer new products and processes at our pre‑pilot 3D Medical Device R&D line, and partner with cross‑functional engineering teams to deliver innovative solutions for pilot line manufacturing programs.

• Develop, maintain, report, and improve pilot line R&D and production KPIs (Safety, Quality, Output, Yield, Availability, etc.).
• Maintain and enhance existing manufacturing control systems and dashboards.
• Implement and refine Lean manufacturing tools, including 5S, constraint identification, and waste elimination.
• Collaborate with cross‑functional design and process teams to meet production and R&D goals.
• Create detailed manufacturing work instructions, operating procedures, and documentation in accordance with Align’s quality policy, focusing on manufacturability and design transfer.
• Train stakeholders on new initiatives.
• Participate in or lead root‑cause analysis and CAPA activities from internal and external audits.
• Partner with cross‑functional engineering groups to evaluate, implement, and improve processes and equipment applications.
• Generate CAD drawings for continuous improvement (layouts, workstations, fixtures, shadow boards).
• Address issues with urgency and meticulous attention to detail.
• Continuously improve existing systems and assist in evaluating and implementing new software tools.
• Optimize processes and implement improvements for transferability and scalability.
• Assist in defining and transferring metrics and processes to high‑volume international plants.
• Thrive in a fast‑paced environment and meet critical deadlines.

• Bachelor’s degree in engineering or a related field.
• Minimum of 4 years’ experience in manufacturing engineering within the medical industry.
• Strong analytical and problem‑solving skills.
• Expertise in MS Office.
• Excellent communication skills.
• Ability to work independently and collaboratively within a high‑functioning team.

• Experience in 3D printing manufacturing.
• Experience in MES and production flow software tools and tool chains.
• Experience in SAP and ERP systems.
• Fluency in Spanish or other languages.

Base salary ranges reflect the range in which Align reasonably expects to set a candidate’s pay for the posted position, adjusted for individual skills, experience, and geographic location. For other locations outside the primary area, the base salary will be adjusted geographically.

Align offers full‑time employees a comprehensive benefits package, including medical, dental, and vision plans, 401(k) with matching, employee stock purchase program, paid vacation, sick leave, and various insurance options. Additional family‑focused benefits such as discounts on Invisalign and Vivera, lactation support, and caregiver concierge services are available after 90 days of employment.

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 other legally protected categories. 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.