Product & Engineering Manager

Description

Role expectations

• Define, communicate and drive the product vision and roadmap for hardware-based products, aligning with company goals and customer needs. 
• Provide technical direction and decision-making across prototyping/feasibility, verification & validation phases of product development. 
• Leads cross-functional development of hardware and software solutions in partnership with engineering teams (biomechanical, materials, process, software) with system-level thinking to ensure successful product delivery from concept to launch. 
• Partner with cross-functional teams, including Marketing, Operations, Quality, Regulatory, and Clinical, to define, prioritize, and validate product requirements and ensure alignment with business and compliance objectives. 
• Support cross functional project teams as subject matter expert (SME) in Design Control and Risk Management ensuring that product development lifecycle complies with medical device regulatory standards (e.g., ISO 13485, FDA 21 CFR Part 820). 
• Champions innovation and differentiation in the hardware product line by analyzing market trends, competitor devices, and emerging technologies to identify opportunities for meaningful product improvement. 
• Monitor product development and risk management processes and identify areas for improvement and implementation of industry best practices. 
• Conduct post-launch monitoring for products to track complaints and identify areas for continuous product improvements. 
• Ensure compliance with regulatory areas and support FDA, Notified Bodies and other regulatory/quality audits and provide support for periodic regional regulatory requests for Invisalign, Vivera and ancillary products as needed.  
• Applies creative problem-solving to overcome technical and programmatic obstacles in a fast-paced, multidisciplinary environment. 

What we're looking for

• Education: Bachelor’s degree or higher in engineering discipline, health science, math or sciences or a related field. 
• Experience: 6+ years of product management or product development experience, Dental Products or Medical Device experience preferred.  
• Skills: Strong analytical and problem-solving abilities; proficiency in requirements gathering, defining product specifications and product strategy. Basic project management skills for research projects. 
• Communication: excellent presentation and communication skills, proven ability to provide technical details while tailoring high-level summaries to suit the needs of different audiences. 
• Teamwork: Ability to work both independently and collaboratively. Foster a culture of innovation, collaboration, and continuous improvement. 
• Self-motivated, self-starter willing to work through ambiguity and strive for continuous improvement. 
• Desire and willingness to develop deep clinical understanding of Invisalign products, dentistry and orthodontics. 

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.