Director, R&D Engineering

Director Of Engineering

Location: Onsite, Irvine, California 6001 Oak Canyon STE 100 (Relocation Available)

Position Overview

The Director of Engineering will play a critical leadership role in ensuring seamless product development and transfer to Global Quality Operations (GQO). This leader will be an expert in process characterization of critical processesdeveloping robust, data-driven methods that anticipate and eliminate transfer risks. The Director will also spearhead Future Technology Development, identifying and shaping patient-centered solutions that address unmet clinical needs, even beyond current technological paradigms.

Key Responsibilities

Process Characterization & Product Transfer

• Establish and lead process characterization frameworks for all critical processes as products are developed, ensuring readiness for seamless transfer to Manufacturing (GQO).
• Apply and institutionalize methodologies such as:
• Design of Experiments (DOE)
• Tolerance Stack-up Analysis
• Failure Modes & Effects Analysis (FMEA)
• Process Capability (Cp, Cpk) Studies
• Statistical Process Control (SPC)
• Monte Carlo Simulations
• Root Cause Analysis & Corrective Action methodologies (e.g., 5-Whys, Fishbone)
• Collaborate cross-functionally with Regulatory, Marketing, Quality, and Manufacturing Engineering to align process development with regulatory requirements and scalability.
• Develop best practices, playbooks, and training programs for process transfer excellence.

Future Technology Development

• Lead the Future Tech Development portfolio by identifying unmet patient and clinical needs that may not rely solely on advanced technology but can deliver transformative patient impact.
• Partner with clinicians, patients, and external innovation networks to surface and evaluate future opportunities.
• Translate unmet needs into clear problem statements, guiding early feasibility assessments and exploratory work.
• Develop pathways for future technology projects, from concept validation through to integration into strategic pipelines.
• Champion physician/patient-first innovation that balances clinical benefit, usability, and access with technical feasibility.

Leadership & Strategy

• Build, mentor, and inspire a high-performing engineering team with expertise in process characterization, technology exploration, and patient-centered design.
• Provide technical and strategic guidance across multiple product lines and development stages.
• Influence organizational decision-making by presenting clear, data-driven insights and future technology opportunities.
• Drive a culture of rigor, innovation, and execution excellence across R&D and GQO interfaces.

Competencies

• Strategic Thinker: Balances near-term execution with long-term innovation.
• Technical Rigor: Expert in data-driven methods for robust product and process development.
• Collaborative Leader: Builds bridges across Regulatory, Quality, Operations, and external stakeholders.
• Innovator: Identifies unmet needs and translates them into tangible patient benefits.
• Physician/Patient-Centric: Anchors all decision-making on improving outcomes and access for patients.

Minimum Qualifications (Required)

• Bachelor of Science degree or higher in Engineering or applicable technical field.
• 12+ years applicable experience, with 6+ years direct people management experience preferred.
• Applicable industry experience may be considered in lieu of a degree.
• Advanced degree in Mechanical Engineering, Biomedical Engineering, or related discipline; PhD preferred.

Required:

• 12+ years of progressive experience in medical devices, biotech, or related regulated industries.
• Deep expertise in process characterization methodologies, with proven success in ensuring smooth transfer of products from R&D to Manufacturing.
• Strong background in statistical methods, experimental design, and process validation.
• Demonstrated ability to lead cross-functional engineering teams and influence senior stakeholders.
• Strong understanding of regulatory frameworks (FDA, ISO, EU MDR) and design control requirements.
• Track record of delivering patient-centered innovation, not limited to high-tech but also practical, unmet-need-driven solutions.

Preferred:

• Experience with Global Quality Operations (GQO) or equivalent manufacturing integration functions.
• Prior leadership of Future Technology/Strategic Innovation portfolios.
• Exposure to multiple therapeutic areas, devices, and global markets.

Technical Skills:

• Broad and comprehensive understanding of, experience in, and ability to mentor in one or more technical/functional disciplines.

$171,900 - $263,300 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 20% Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability. Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information.