Hybrid Principal Software Development Lifecycle Process Owner

at Stryker

• Job title: Principal Software Development Lifecycle Process Owner
• Job type: Full Time
• Experience level: Lead
• Salary: $135,600 - $293,700 per year
• Degree requirement: Bachelor's Degree
• Tech skills: SDLC
• Location requirements: Hybrid, Portage, United States

About the role

• Lead Ortho Tech’s SDLC processes ensuring compliance with Stryker regulations and industry standards. Guide new product development teams integrating risk management into product and software development.

Responsibilities

• 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.

Requirements

• 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.
• 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.

Benefits

• Salary plus bonus eligible + benefits