Startup line Engineer

About the role

Join our Research and Development team as a 3D Printed Medical Device Startup Line Engineer. This role focuses on manufacturability of medical devices and involves collaborating with a small team to produce custom medical devices using cutting-edge 3D printing technology.

Responsibilities

• 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, with a focus 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 (e.g., 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
• Aid in defining and transferring metrics and processes to high-volume international plants

Requirements

• 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 both independently and collaboratively within a high-functioning team

Qualifications

• Preferred: Experience in 3D printing manufacturing
• Preferred: Experience in MES and production flow software tools and toolchains
• Preferred: Experience in SAP and ERP systems
• Preferred: Fluency in Spanish or other languages

Skills

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

Benefits

• Family Benefits
• Family Forming Benefits
• Employee Assistance Program
• Hinge Health Virtual Physical Therapy
• Short-term and long-term disability insurance
• Basic Life Insurance and Accidental Death and Dismemberment
• Voluntary Supplemental Life Insurance
• Flexible Spending Accounts
• 401k plan
• Employee Stock Purchase Program
• Paid vacation
• Sick time
• Company-designated paid holidays
• Paid Parental Leave
• Paid Bereavement Leave
• Jury Duty Leave
• Other insurance options

Pay

If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically. For Field Sales roles, the salary listed is the base pay only and does not include the applicable incentive compensation plan. A cost of living adjustment may be added to base pay for higher cost areas in the U.S.