Director, R&D Engineering
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Job Location:
Irvine, CA - USA
Monthly Salary:
$ 171900 - 263300
Posted on:
16-10-2025
Vacancies:
1 Vacancy
Job Summary
Work Flexibility: Hybrid or Onsite
Location: Onsite California Irvine 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.
$171900 - $263300 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 unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information.Required Experience:
Director
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
