Align Technology · 2 weeks ago
Sr. Packaging and Labeling Product Engineer
San Jose, CA
Full-time
Onsite
Senior Level
$137K/yr - $189K/yr
6+ years expAlign Technology is seeking a Senior Packaging and Labeling Product Engineer to lead critical packaging and labeling initiatives. This role is essential for driving compliance, innovation, and operational excellence for Global Medical Device, focusing on quality systems, regulatory compliance, and process improvement.
HardwareHealth CareManufacturing
Responsibilities
Maintain and enhance packaging and labelling quality systems in compliance with Global Regulatory and Legal requirements
Develop and refine SOPs, work instructions, and other quality documentation
Lead change management for packaging and labelling, ensuring smooth implementation of lifecycle changes
Review and manage label change requests (LCR) to ensure compliance and timely updates
Manage packaging and labelling initiatives from concept to implementation
Develop scopes, timelines, and risk mitigation strategies to ensure compliance with regulatory standards
Identify opportunities for efficiency within labelling workflows and implement best practices
Drive continuous improvement to enhance compliance, productivity, and cost-effectiveness
Provide expertise in root cause analysis and corrective actions for packaging and labelling issues
Ensure specifications meet regulatory and process standards
Collaborate with quality assurance, regulatory affairs, manufacturing, engineering, operations, product management, PMO, and supply chain teams
Support product launches and regulatory updates to achieve timely and compliant product releases
Travel ~30%
Qualification
Required
Bachelor's degree in Engineering, Regulatory Affairs, or a related field
Minimum 6 years of experience in global medical device and/or pharmaceutical packaging and labelling
Deep understanding of global regulatory, legal, and carrier compliance standards
Expertise in quality systems, label equipment and related end to end systems, artwork review, and regulatory compliance
Proven ability to manage multiple projects effectively
Strong collaboration and influencing abilities across departments
Experience with implementation and execution of program and enterprise risk management
Familiarity with Root Cause Analysis and Operational Excellence methodologies such as LEAN, DMAIC, Six Sigma
Benefits
Medical (with a Health Savings Account option for some plan offerings)
Dental
Vision
Discounts on Invisalign and Vivera to employees and their eligible dependents after 90 days of employment
Back-up Child/Elder Care and access to a caregiving concierge
Family Forming Benefits – Available to Employees, and their spouse or domestic partner, covered under one of Align’s health plans
Breast Milk Delivery and Lactation Support Services
Employee Assistance Program
Hinge Health Virtual Physical Therapy – Available to all employees and eligible dependents (age 18+) enrolled in an Align medical Plan
Short-term and long-term disability insurance in accordance with those plans
Basic Life Insurance and Accidental Death and Dismemberment
Voluntary Supplemental Life Insurance for Employee, Spouse/Domestic Partner, and Child(ren) are available for purchase in accordance with those plans
Flexible Spending Accounts – Employees may be eligible to participate in a health care account (including a limited health FSA if enrolled in a HDHP), dependent care account, and a pre-tax commuter benefit plan
401k plan (with a discretionary Company match of 50% up to 6% of eligible earnings up to a maximum match of 3%)
Employee Stock Purchase Program (Employees must work 20 hours or more and be employed on purchase date to be eligible)
Paid vacation of up to 17 days during the first full year of employment (currently accrued at the rate of 5.24 hours each pay-period), which carries over to a maximum cap of 30 days
Sick time is accrued throughout the year at the rate of one hour for every thirty worked
11 Company-designated paid holidays throughout the year
Up to 6 weeks of paid Parental Leave if employed for at least 12 consecutive months
Three days of paid bereavement leave
Non-exempt employees will receive full pay for up to 10 days of jury duty
Company
Align Technology
Align Technology, Inc. designs, manufactures, and markets the invisalign system for treating malocclusion or the misalignment of teeth.
10001+ employees
H1B Sponsorship
Align Technology has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (75)
2024 (57)
2023 (49)
2022 (60)
2021 (66)
2020 (31)
Funding
Current Stage
Public CompanyTotal Funding
$136MKey Investors
QuestMark PartnersComdisco Ventures
2001-01-26IPO
2000-06-21Series D· $105M
1999-10-07Series Unknown· $26M
Leadership Team
Joseph Hogan
CEO, President, and Director
Ben Park
Head, Emerging Technology | Research & Development
Recent News
Morningstar.com
2025-12-29
2025-12-11
Company data provided by crunchbase