Senior Director, New Product Development

Salary Range: $202,500.00 - $337,500.00

Job Description:

Confluent Medical Technologies is a financially healthy and rapidly growing medical device company whose employees are passionate about providing life-saving solutions to our customers through a collaborative and high-impact work environment. Our moderate size, diversity of technologies, and broad material science capabilities provide an environment in which our employees can develop broad skill sets and directly influence product development and manufacturing outcomes.

We are looking for a Senior Director, New Product Development to join our talented team!

Position Summary

The Senior Director, New Product Development serves as a senior engineering and product development leader within Confluent Medical. This position is responsible for establishing and executing the technical, organizational, and product development strategy supporting the development of innovative medical device technologies and products across the enterprise.

The role provides leadership for a multi-site organization responsible for the development, commercialization, and transfer of medical technologies, products, and manufacturing solutions. The Senior Director leads cross-functional teams focused on bringing customer and internally sponsored product development programs from concept through commercialization and manufacturing transfer.

The Senior Director is accountable for product development portfolio execution, technology strategy, engineering excellence, organizational capability, customer satisfaction, and long-term business growth. This position partners closely with Commercial, Operations, Quality, Regulatory, Program Management, and Manufacturing organizations to align technical investments with customer and business objectives.

This leader directly influences customer growth opportunities, technology investment decisions, engineering capabilities, manufacturing readiness, and strategic direction across the organization.

Key Responsibilities

Business & Technology Leadership

• Develop and execute the long-term product development and technology strategy supporting Confluent's business objectives.
• Establish technical roadmaps aligned with business growth objectives, customer needs, and emerging market opportunities.
• Partner with Commercial leadership to identify and prioritize growth opportunities, technology investments, and strategic customer initiatives.
• Influence business strategy through evaluation of market trends, technology developments, competitive positioning, and customer requirements.
• Support strategic planning processes, including annual operating plans, capital planning, and long-range business objectives.

Product Development Portfolio Leadership

• Provide executive leadership for a portfolio of customer-funded and internally sponsored development programs.
• Establish portfolio governance processes and investment priorities.
• Balance technical, financial, operational, and organizational considerations when prioritizing resources and development activities.
• Ensure successful execution of development programs from concept through commercialization and manufacturing transfer.
• Drive accountability for program execution, resource utilization, financial performance, and customer satisfaction.

Technology & Innovation Strategy

• Establish and advance technology strategies supporting current and future customer and market needs.
• Identify, evaluate, and develop emerging technologies that enhance Confluent's competitive position.
• Drive innovation through the development of new capabilities, processes, products, and engineering solutions.
• Assess organizational technical capabilities and establish investment recommendations supporting future business growth.
• Promote technical excellence and continuous improvement across all product development activities.

Organizational Leadership

• Lead a multi-disciplinary organization consisting of Directors, Managers, Engineers, Scientists, and Technical Personnel.
• Build long-term organizational capability through workforce planning, succession planning, and leadership development.
• Develop future engineering leaders and critical technical talent.
• Ensure organizational structures support scalable growth and business objectives.
• Foster a culture of innovation, accountability, collaboration, customer focus, and continuous improvement.

Customer Leadership

• Serve as executive technical sponsor for strategic customer relationships.
• Participate in executive customer reviews, opportunity pursuits, technical strategy discussions, and critical business negotiations.
• Support customer acquisition, retention, and expansion efforts.
• Build and maintain trusted relationships with senior technical and business leaders across key customer organizations.

Manufacturing & Commercialization Leadership

• Ensure products and technologies are developed using Design for Manufacturability principles.
• Partner with Operations and Manufacturing Engineering leaders to ensure successful technology transfer and commercialization.
• Drive transfer strategies supporting production scale-up across Confluent manufacturing locations.
• Ensure alignment between product development investments and operational capabilities.

Quality, Regulatory & Compliance Leadership

• Ensure compliance with FDA, ISO 13485, Design Controls, Risk Management, and Quality System requirements.
• Establish robust risk management practices throughout the development organization.
• Promote a quality-focused culture supporting regulatory compliance and successful inspections.

Financial & Operational Management

• Develop and manage departmental operating budgets, capital plans, and resource strategies.
• Establish key performance indicators and organizational objectives.
• Monitor portfolio performance, organizational effectiveness, customer satisfaction, and business results.
• Drive improvements in productivity, efficiency, quality, and speed-to-market.

Education & Experience

Required

• Bachelor's degree in Engineering, Biomedical Engineering, Materials Science, Mechanical Engineering, Chemical Engineering, Life Sciences, or a related technical discipline.
• 18+ years of progressive engineering, product development, and technical leadership experience within the medical device industry.
• 10+ years of leadership experience directing managers and senior technical leaders.
• Demonstrated success leading large, multi-functional product development organizations.
• Extensive experience with Class II and Class III medical device development from concept through commercialization.
• Strong expertise in Design Controls, Risk Management, Verification & Validation, Process Development, and Manufacturing Transfer.
• Demonstrated success managing large technical portfolios, strategic customer relationships, and complex engineering organizations.
• Experience influencing business strategy and technology investment decisions.

Preferred

• Master's degree, MBA, PhD, or other advanced degree.
• Experience supporting cardiovascular, structural heart, electrophysiology, neurovascular, peripheral vascular, surgical, orthopedic, robotic, minimally invasive, or other medical device markets.
• Experience within a contract development and manufacturing (CDMO) environment.
• Lean Six Sigma Green Belt, Black Belt, or equivalent certification.
• PMP certification.
• Experience supporting multi-site global development and manufacturing organizations.

C onfluent Medical Technologies is dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components and tubing, balloon expandable stents and catheters, complex catheters, biomedical textiles, and high precision polymer tubing. We take pride in our position as the leader in the medical technology space and are driven by a passion to create products that our clients have envisioned for their customers.

The posted salary range reflects the Fremont, CA market. Final compensation will be determined based on a variety of factors, including skills, experience, qualifications, and geographic location.

We regret that we are unable to sponsor employment visas or consider individuals on time-limited visa status for this position.

Confluent Medical Technologies is an equal opportunity employer.

Only qualified candidates will be contacted.