Principal Software Development Lifecycle (SDLC) Process Owner
About The Position
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.
Nice To Haves
- 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.
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
