Sr. R&D Engineer, New Products

Description

Role expectations

• Lead product development workstreams from concept through launch, including planning, execution, and cross-functional coordination
• Design, prototype, and evaluate product concepts using biomechanical models, benchtop methods, and experimental testing
• Develop and execute verification and validation activities to assess product performance and design robustness
• Design, build, and verify test hardware, fixtures, and systems, including automation tools, as needed to support product development
• Apply sound mechanical and engineering principles to understand, model, and solve problems involving complex systems
• Perform statistical analysis and interpret data to guide technical decisions and product improvements
• Communicate technical findings, recommendations, and product insights effectively to stakeholders at all levels
• Collaborate with cross-functional partners to incorporate design inputs, technical requirements, and user needs into product prototypes and final designs
• Partner with Clinical Affairs and cross-functional teams to support clinical studies and other product investigations
• Generate clear, complete technical documentation in compliance with FDA, ISO, and internal medical device development requirements, including protocols, reports, and design documentation
• Contribute to invention generation, intellectual property development, and patent disclosures
• Prioritize and execute work effectively in a fast-paced environment with evolving priorities and critical timelines
• Provide broad engineering support as needed

What we're looking for

• B.S. in Mechanical Engineering, Biomedical Engineering, or a related field with 8+ years of experience in biomedical research and/or product development
• M.S. in Mechanical Engineering, Biomedical Engineering, or a related field with 6-7 years of experience in biomedical research and/or product development
• Ph.D. in Mechanical Engineering, Biomedical Engineering, or a related field with 3-5 years of experience in biomedical research and/or product development
• Higher or lower years of experience will be considered for this role, with job level and title adjusted accordingly

• Strong theoretical and experimental background in structural mechanics and biomechanics
• Experience with 3D CAD solid modeling and mesh-based modeling tools
• Test method development, verification, and validation
• Data analysis, scripting, and automation for experimental and design workflows
• Additive manufacturing (3D printing) for test fixtures, prototypes, and end-use product applications
• Experience in the medical device industry

Pay Transparency

• 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%.). 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 (currently accrued at the rate of 5.24 hours each pay-period), which carries over to a maximum cap of 30 days.  Annual paid vacation time accrual increases based on tenure. Both exempt and non-exempt employees who work 32 hours or more per week receive prorated vacation accrual based on their regularly scheduled work hours and tenure.
• Sick time is accrued throughout the year at the rate of one hour for every thirty worked. Employees can carry over unused sick leave each year, up to a maximum balance of 80 hours.
• 11 Company-designated paid holidays throughout the year.
• If employed for at least 12 consecutive months, Align will grant up to 6 weeks of paid Parental Leave. If employed for less than 12 consecutive months, Align will grant up to 4 weeks of paid Parental Leave.  All parental leave must be completed within one year of the birth or placement of the child.  Parental leave is in addition to any state and/or local parental leave benefits. Three days of paid bereavement leave. In some cases, due to travel the amount of paid leave may be extended to 5 paid days off. To the extent applicable state or local law offers more generous benefits, Align complies with any such law.
• Non-exempt employees will receive full pay for up to 10 days of jury duty.  Exempt employees will receive their full salary during any week they serve and perform any work. Other insurance such as legal, critical illness, voluntary accident, long-term care, auto, home and pet insurance are available for purchase.