Principal Software Development Lifecycle (SDLC) Process Owner

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.

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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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.