Stryker · 2 days ago
Principal Software Development Lifecycle (SDLC) Process Owner
Stryker is a leading medical technology company, and they are seeking a Principal Software Development Lifecycle (SDLC) Process Owner. The role involves leading SDLC processes, guiding product development teams, and ensuring compliance with regulatory standards while promoting Agile practices.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
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
Qualification
Required
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
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
Bonus eligible
Benefits
Company
Stryker
Stryker is a medical technology company that offers products and services in orthopaedics.
H1B Sponsorship
Stryker has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)
Funding
Current Stage
Public CompanyTotal Funding
unknown1990-01-02IPO
Recent News
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2025-02-11
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