Principal Software Development Lifecycle (SDLC) Process Owner jobs in United States
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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
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Growth Opportunities
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H1B Sponsor Likelynote

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

SDLC expertiseAgile methodologiesRegulatory complianceSoftware developmentProject managementAnalytical skillsCommunication skillsInterpersonal skills

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 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 Company
Total Funding
unknown
1990-01-02IPO

Leadership Team

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Kevin Lobo
Chair & CEO
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Glenn S. Boehnlein
Chief Financial Officer and Vice President
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Company data provided by crunchbase