Principal Engineer, Design Development, R&D

Position Summary

The Principal Engineer, R&D serves as a senior technical leader responsible not only for driving product innovation and development, but also for building and strengthening organizational engineering capability. 
In addition to leading complex product development initiatives, the Principal Engineer fosters a culture of learning, mentorship, and continuous improvement, playing a critical part in developing junior talent, elevating technical excellence, and establishing scalable engineering practices across the organization.

The focus is on helping to grow the next generation of engineering leaders while advancing the company’s innovation and competitive position.

Principal Responsibilities

•    Technical Leadership & Strategy
•    Lead end-to-end product development across multiple programs, including design, verification/validation, risk management, and commercialization.
•    Define engineering strategy, standards, and best practices that enable scalable and repeatable success.
•    Influence product roadmaps and innovation priorities aligned with business objectives.
•    Serve as a senior technical authority across teams, providing guidance on complex engineering challenges.

•    Talent Development & Organizational Capability Building (Primary Focus)
•    Mentor and develop junior and mid-level engineers, accelerating their technical growth, decision-making capability, and leadership readiness.
•    Establish structured coaching, feedback, and knowledge-sharing practices across the NPD organization.
•    Lead technical training, design reviews, and learning forums to disseminate best practices.
•    Define and promote engineering competencies, career development frameworks, and skill progression pathways.
•    Foster a culture of innovation, accountability, and continuous improvement.
•    Identify organizational capability gaps and implement plans to strengthen technical depth and bench strength.

•    Product Development Execution
•    Deliver high-quality, compliant medical devices on time and within budget.
•    Lead design control processes in accordance with FDA and ISO 13485 standards.
•    Ensure robust engineering execution across specifications, materials, and manufacturing processes.
•    Drive continuous improvement of existing products, focusing on quality, cost, and manufacturability.

Education / Experience Requirements

•    Required
•    Bachelor’s degree in engineering (Mechanical, Biomedical, or related field)
•    15+ years of experience in medical device R&D or product development
•    Proven history of delivering regulated products to market
•    Demonstrated experience mentoring, coaching, and developing engineering talent

•    Preferred 
•    Master’s degree in engineering or related field
•    Deep expertise in design controls, verification & validation, and risk management
•    Strong knowledge of FDA, ISO 13485, and global regulatory requirements
•    Experience building engineering processes, frameworks, or organizational capabilities

Specialized Skills / Other Requirements

•    Cross-Functional Collaboration
•    Partner closely with Marketing to translate user needs into product requirements.
•    Collaborate with Quality, Regulatory, Clinical, Manufacturing, and Supply Chain teams.
•    Interface with clinicians, external partners, and vendors to inform product design and development.
•    Support regulatory submissions, audits, and clinical evaluations.

•    Leadership & Influence
•    Lead and influence cross-functional and matrixed teams without direct authority.
•    Model strong leadership behaviors, including accountability, collaboration, and technical rigor.
•    Elevate team performance by setting clear expectations, fostering engagement, and recognizing contributions.
•    Function as a trusted advisor to leadership on technical strategy and organizational development.

•    Innovation & Portfolio Development
•    Identify and develop new product concepts and technology opportunities.
•    Contribute to a differentiated and competitive R&D portfolio.
•    Stay current with industry trends, emerging technologies, and competitive landscape.
•    Support long-term R&D planning, investment decisions, and capability expansion.

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