Head of Mechanical Engineering & R&D

About Proclaim

Proclaim is transforming oral health through a novel, clinically validated, personalized, and automated oral care system that delivers a professional-level clean at home in just 7 seconds. Using a custom-fit mouthpiece with up to 60 precision water jets, Proclaim cleans between teeth and below the gumline to provide a comprehensive 360-degree deep clean with every use. By making effective oral care effortless and measurable, Proclaim is improving both oral and systemic health outcomes. We are building a company that defines the category at the intersection of medical devices, healthcare, and AI-driven oral health intelligence.

Why This Role Exists

We are seeking a hands-on technical leader to lead our Mechanical Engineering and R&D function. This role will own the design, development, and commercialization of our products, lead cross-functional product development efforts across Engineering, Operations, Quality, Regulatory, and Manufacturing, while building and leading a high-performing engineering team as we scale.

This is a critical leadership position responsible for translating product concepts into manufacturable, high-quality medical devices that meet clinical, regulatory, and business requirements.

The ideal candidate brings deep expertise in mechanical product design, injection molded components, fluid dynamics, and performance optimization, including the ability to reverse engineer existing Proclaim products and elevate design performance through structured engineering analysis, test driven improvements, and manufacturable innovation. This leader must have experience working closely with contract manufacturers and joint development partners across both the US and Asia.

Location: On-site, San Carlos, CA (0.7 mi from Caltrain)

What you will do

Product Development & Technical Leadership

• Lead end-to-end product development activities from concept generation through design verification, validation, transfer to manufacturing, and commercialization with the focus on design for total cost, quality, and scale.
• Specify, design, verify, and validate products in accordance with FDA and international medical device regulatory standards.
• Drive innovative mechanical system design with strong emphasis on injection molded components, assemblies, tolerance analysis and long-term reliability
• Provide technical leadership in fluid dynamics, flow characterization, and performance optimization to ensure products consistently meet functional, clinical, and quality requirements.
• Conduct design reviews, risk analyses (including DFMEA and PFMEA), and root cause investigations.
• Develop and execute verification and validation protocols and reports.
• Develop and implement robust measurement methods, engineering characterization techniques, and validation strategies to confirm product performance and reliability.
• Apply efficient analytical, experimental, and data-driven engineering methodologies to optimize product functionality and develop next-generation design improvements
• Develop engineering test platforms, fixtures, and automated test methodologies to support characterization, verification, reliability testing, and ongoing product quality.
• Apply strong Design for Manufacturability (DFM), Design for Assembly (DFA), and Design for Cost (DFC) principles to optimize cost scalability, manufacturability, and product quality.
• Drive structured root cause analysis and engineering problem-solving activities to improve product robustness and field performance.
• Integrate industrial design and functional requirements into robust mechanical CAD models.
• Develop engineering drawings, work instructions, and technical documentation.
• Create and manage Engineering Change Orders (ECOs).

Manufacturing & Supplier Development

• Collaborate with Regulatory and Quality leadership to ensure compliance with FDA regulations, ISO 13485 requirements, risk management standards, and design control processes.
• Lead technical collaboration with contract manufacturers and joint development partners in both the US and Asia to support development, scale-up, supplier qualification, and manufacturing readiness.
• Support manufacturing transfer activities and ongoing production improvements through close collaboration with Manufacturing and supplier partners.
• Identify design and process improvement opportunities during builds.
• Partner with Operations and Quality to evaluate supplier capabilities and build a robust supply chain.
• Support DFM, fit checks, first article inspections (FAI), process capability studies (Cpk), and production qualification activities.
• Troubleshoot manufacturing issues and implement both short- and long-term corrective actions.
• Communicate effectively with overseas suppliers and manufacturing partners.

Leadership & Team Building

• Lead, mentor, and develop a growing team of mechanical engineers, technicians, and external development partners.
• Establish engineering processes, development standards, documentation practices, and technical review mechanisms that support scalable product development.
• Foster a culture of technical excellence, accountability, collaboration, and continuous improvement.
• Assess future organizational needs and recruit top engineering talent as the company scales.
• Provide clear prioritization and coaching to ensure team members are aligned with company objectives.

Cross-Functional Collaboration

• Partner closely with Quality, Regulatory, Operations, Supply Chain, Clinical, and Manufacturing teams throughout the product lifecycle.
• Partner closely with the VP of Product on roadmap development.
• Support technical discussions with executive leadership and external partners.
• Contribute to strategic planning, budgeting, and product roadmap development.

Required Qualifications

• Bachelor's Degree (Mechanical Engineering or equivalent engineering or scientific discipline)
• 7+ years of experience in mechanical engineering and product development within the medical device or MedTech industry.
• 5+ years of experience leading or mentoring engineering teams.
• Strong understanding of medical device materials and manufacturing processes.
• Strong understanding of fluid mechanics principles and experience designing with fluid mechanics in mind.
• Deep expertise in mechanical design with strong hands-on experience in injection molding, plastic part design, and complex assemblies
• Strong understanding of fluid mechanics principles and experience designing with fluid mechanics in mind.
• Experience developing test methods, validation protocols, engineering fixtures, and product performance test platforms.
• Demonstrated experience reverse engineering and improving existing product designs to enhance performance, quality, reliability, and manufacturability.
• Experience with DFM, fit checks, FAI, and Cpk.
• Experience with achieving functional safety certifications such as Ul and IEC
• Strong knowledge of GD&T and tolerance stack analysis.
• Working knowledge of electrical, RF, and electro-mechanical systems.
• Experience with BOM and PLM management.
• Proficiency in SolidWorks and/or Creo.
• Experience collaborating with contract manufacturers and development partners in Asia and the US.
• Strong written and verbal communication skills.
• Demonstrated ability to troubleshoot issues during builds and develop practical solutions.
• Ability to operate effectively in fast-paced, evolving environments while driving alignment across technical, commercial, and operational teams

Preferred Qualifications

• Experience with electromechanical or consumer-oriented medical products.
• Strong technical program management and program leadership capabilities
• Advanced degree in Mechanical Engineering or related discipline.

Benefits

• Total compensation $240k - $280k per year
• Health, Dental and Vision, including PPO, HMO/EPO and HDHP. 90% employee + 50% dependent coverage
• Retirement options: 401(k), IRA
• Commuter benefits
• Robust benefit options through our PEO including Life/ AD&D, disability insurance, global travel assistance, identify theft, HSA, FSA Medical & Dependent care
• Employee Assistance Programs
• Physical, emotional, and financial wellbeing perks
• Mostly in-person in the office. Generous vacation & fun team events

We built our benefits package to exemplify our commitment to health, a work/life balance that fulfills you while you’re here and supports you when you’re not (and some added fun).

Why Join Proclaim

This is a rare opportunity to lead the development of a category-defining medical device platform with the potential to transform oral and systemic health. You will play a pivotal role in shaping both the product and the engineering organization as the company scales.