Summary
About this role
What You Will Do
Lead Ortho Tech’s SDLC processes, ensuring compliance with Stryker policies, regulations, and industry standards.
Guide new product development teams in integrating SDLC, design controls, risk management, and traceability into product and software development.
Champion Agile best practices (Scrum, Kanban, scaled Agile) and ensure alignment with SDLC and regulatory expectations.
Coach teams on incorporating compliance requirements into Agile iterations without impacting velocity or execution.
Establish and monitor Agile and SDLC metrics/KPIs to assess performance and drive continuous improvement.
Provide SDLC expertise and support for products across pre‑market and post‑market phases.
Lead SDLC initiatives, represent the function on review boards, and contribute to global and divisional process development.
Support and/or lead internal and external regulatory audits, including narrative explanation, preparation, and logistics.
Provide training, coaching, and mentorship on software development, SDLC processes, and best practices.
Communicate progress, risks, and global SDLC initiatives to leadership and stakeholders while collaborating cross‑functionally across Ortho Tech.
What You Need (Required Qualification)
BS or Master in Software Engineering, Computer Science or related discipline.
Minimum of 8+ years experience expected.
Previous SDLC experience working in a highly regulated environment.
Preferred Qualifications (Strongly Desired)
Strong software development expertise with knowledge of U.S. and international SDLC regulations and standards (e.g., FDA, MoH, TUV, ISO 13485, GDP, GMP).
Excellent communication, influencing, and project management skills with the ability to manage multiple priorities.
Proven ability to represent SDLC effectively across cross‑functional teams and work collaboratively in a matrixed environment.
Strong interpersonal, written, verbal, and negotiation skills.
Advanced analytical, critical‑thinking, and problem‑solving abilities.
Experience navigating compliance‑driven environments and interacting with regulatory agencies.
$135,600 - $293,700 salary plus bonus eligible + 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 contractor’s legal duty to furnish information.Other facts
About Stryker
Stryker is a global leader in medical technologies and, together with our customers, we are driven to make healthcare better. We offer innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. More information is available at stryker.com and careers.stryker.com.
Facts:
● 2024 Sales: $22.6 billion
● Industry: Medical Instruments & Supplies
● Employees: 53,000 worldwide
● 40 years of sales growth leading up to 2020
● 44+ Manufacturing and R&D Locations Worldwide
● $1.5 billion spent on research and development in 2024
● ~14,200 patents owned globally in 2024
● Products sold in ~75 countries
● Fortune 500 Company
● 7 consecutive years as one of Fortune's World's Best Workplaces
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What you'll do
- Lead the SDLC processes for Ortho Tech, ensuring compliance with policies and regulations. Coach teams on integrating SDLC with Agile methodologies while monitoring performance metrics.
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