Align Technology
Sr. Packaging and Labeling Product Engineer
Align Technology, San Jose, California, United States, 95199
Senior Packaging and Labeling Product Engineer
Department:
Marketing
Location:
US-California-San Jose
Compensation:
$137,200 - $188,700 / year
Description:
The Senior Packaging and Labeling Product Engineer will lead critical packaging and labelling initiatives. This role is essential for driving compliance, innovation, and operational excellence for Global Medical Device. If you have expertise in quality systems, regulatory compliance, project management, and process improvement, we want to hear from you. This role will be located in San Jose, CA and have no direct reports.
Role expectations
Quality Systems Oversight:
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.
Change Management:
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.
Process Improvement:
Identify opportunities for efficiency within labelling workflows and implement best practices.
Drive continuous improvement to enhance compliance, productivity, and cost-effectiveness.
Technical Support and Troubleshooting:
Provide expertise in root cause analysis and corrective actions for packaging and labelling issues.
Ensure specifications meet regulatory and process standards.
Cross-Functional Collaboration:
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%.
What We're Looking For
Education: Bachelor’s degree in Engineering, Regulatory Affairs, or a related field.
Experience: Minimum 6 years of experience in global medical device and/or pharmaceutical packaging and labelling.
Regulatory Knowledge: Deep understanding of global regulatory, legal, and carrier compliance standards.
Technical Skills: Expertise in quality systems, label equipment and related end-to-end systems, artwork review, and regulatory compliance.
Project Management: Proven ability to manage multiple projects effectively.
Communication Skills: 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
Family Benefits: Align offers employees and their eligible dependents medical (with a Health Savings Account option for some plan offerings), dental, and vision in accordance with those plans.
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 Children available for purchase.
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%). Employer match vests after two years – 25% year one and 100% at year two. Align offers traditional, Roth, and after-tax options.
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, with accrual of up to a maximum cap of 30 days.
Sick time is accrued throughout the year at the rate of one hour for every thirty worked, with a maximum balance of 80 hours.
11 Company-designated paid holidays throughout the year.
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.
Applicant Privacy Policy Review our Applicant Privacy Policy for additional information.
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Marketing
Location:
US-California-San Jose
Compensation:
$137,200 - $188,700 / year
Description:
The Senior Packaging and Labeling Product Engineer will lead critical packaging and labelling initiatives. This role is essential for driving compliance, innovation, and operational excellence for Global Medical Device. If you have expertise in quality systems, regulatory compliance, project management, and process improvement, we want to hear from you. This role will be located in San Jose, CA and have no direct reports.
Role expectations
Quality Systems Oversight:
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.
Change Management:
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.
Process Improvement:
Identify opportunities for efficiency within labelling workflows and implement best practices.
Drive continuous improvement to enhance compliance, productivity, and cost-effectiveness.
Technical Support and Troubleshooting:
Provide expertise in root cause analysis and corrective actions for packaging and labelling issues.
Ensure specifications meet regulatory and process standards.
Cross-Functional Collaboration:
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%.
What We're Looking For
Education: Bachelor’s degree in Engineering, Regulatory Affairs, or a related field.
Experience: Minimum 6 years of experience in global medical device and/or pharmaceutical packaging and labelling.
Regulatory Knowledge: Deep understanding of global regulatory, legal, and carrier compliance standards.
Technical Skills: Expertise in quality systems, label equipment and related end-to-end systems, artwork review, and regulatory compliance.
Project Management: Proven ability to manage multiple projects effectively.
Communication Skills: 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
Family Benefits: Align offers employees and their eligible dependents medical (with a Health Savings Account option for some plan offerings), dental, and vision in accordance with those plans.
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 Children available for purchase.
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%). Employer match vests after two years – 25% year one and 100% at year two. Align offers traditional, Roth, and after-tax options.
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, with accrual of up to a maximum cap of 30 days.
Sick time is accrued throughout the year at the rate of one hour for every thirty worked, with a maximum balance of 80 hours.
11 Company-designated paid holidays throughout the year.
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.
Applicant Privacy Policy Review our Applicant Privacy Policy for additional information.
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