Full-Time
Senior Software Engineer
Csv
Posted on 12/13/2025
Stryker
10,001+ employees
Manufactures orthopedic and surgical medical devices
No salary listed
Noida, Uttar Pradesh, India
Hybrid
 Software Engineering (1) |
|---|
- Experience of 5-8 years
- technical ability such as a sound knowledge of quality principles (e.g. ISO 13485) and computer system development lifecycles
- keen attention to detail with natural curiosity and learning agility
- good communication skills across a wide range of departments within the organization and an ability to engage with stakeholders to achieve the business objective
- a resilient, agile nature with the excellent organizational ability to be able to prioritize your workload to meet deadlines and deliver in a constantly changing environment
- Author, Review, and Approve CSV deliverables Validation Project Plan with different Stakeholders
- Follow Computer Systems Validation, CSV, Processes to the author, review and approve CSV deliverables for systems
- Take ownership of the CSV and Equipment Qualification effort on different Hardware and Software Tools and fixtures being used across different Teams
- Co-ordinate with the different teams for understanding their requirements and validate the system accordingly
- Review and identify validation deviations and resolve deviations with appropriate corrective/preventive actions
- Directly work with QA/Design/Test teams for implementing new and upgrading previously validated systems
- Organize and attend the meeting to discuss the status of the projects
- Create and provide computer validation training programs to ensure Regulatory Compliance
- Assess risks related to the systems and analyze them, if necessary with the Team
- Review and follow SOPs to help the business process in line with FDA regulations
- Follow the risk analysis process, assessment process, and change control procedures for different systems as per Stryker rules and regulations
- documentation – writing, maintaining, reviewing and updating validation documentation, and approving validation SOPs
- reviewing validation data, compiling reports and contributing to internal audits and external inspections as they arise
- proposing and implementing process upgrades and efficiency improvements
- keeping on top of advances in the field and, in particular, updates to the regulatory requirements
- training staff on the computerized systems in line with the relevant protocols and regulations
- Familiarity with Medical standards & FDA requirements
- Basic Knowledge of any Programming language
- Excellent documentation and Written/Verbal communication skills
- Must be flexible, independent, and self-motivated
Stryker designs, manufactures, and sells medical devices across multiple areas, including surgical equipment, neurotechnology, and orthopedic implants, to hospitals and clinics worldwide. Its products are developed through engineering and clinical input, then manufactured and distributed to healthcare providers who use them during procedures to improve patient care and surgical efficiency. Stryker differentiates itself from competitors with a broad, integrated portfolio, a global sales and service network, and a strong emphasis on quality and ongoing product development to support safer, more efficient procedures. The company’s goal is to advance patient outcomes by delivering reliable, effective medical devices that expand access to care globally.
Company Size
10,001+
Company Stage
IPO
Headquarters
Kalamazoo, Michigan
Founded
1941
Simplify's Take
What believers are saying
- Robotic surgery leadership drives double-digit sales growth through 2025.
- India Trident II launch targets aging population's rising hip surgeries.
- Peripheral vascular expansion via IVL meets growing arterial disease demand.
What critics are saying
- Handala cyberattack on March 11 delays ortho supply chain 3-6 months.
- Zimmer Biomet Persona IQ erodes ortho share with real-time analytics.
- J&J Velys captures 25% more knee procedures from Mako in 6-12 months.
What makes Stryker unique
- Stryker holds 39.1% US market share in orthopedic product manufacturing.
- Trident II Acetabular System integrates Mako SmartRobotics for hip replacements.
- Amplitude Vascular Systems acquisition adds CO₂ IVL for peripheral arteries.
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Benefits
Medical & prescription plans
Supplemental health benefits
Flexible Spending accounts
Employee Assistance Program
Short-term & long-term disability
Tuition reimbursement
401(k) plan
Employee Stock Purchase Plan
Company News
Distalmotion targets ASC gynecology programs with new FDA filing Distalmotion has submitted a 510(k) application to the FDA seeking to expand the label of its Dexter robotic surgery system into additional gynecological indications, the company announced April 1. The filing covers sacrocolpopexy, sacrocervicopexy and endometriosis resection. Sacrocolpopexy and sacrocervicopexy are procedures used to treat pelvic…
Stryker Corporation has signed a definitive agreement to acquire Amplitude Vascular Systems, a Boston-based medical technology company developing next-generation intravascular lithotripsy technology for treating calcified peripheral arterial disease. Financial terms were not disclosed. AVS's technology uses pulsed CO₂-generated pressure waves delivered through a balloon catheter to fracture calcium deposits. The platform aims to enhance catheter deliverability, treatment speed and therapy efficiency. The acquisition will strengthen Stryker's peripheral vascular portfolio and expand its presence in arterial disease treatment. Stryker CEO Kevin Lobo said the deal advances the company's vision to build a comprehensive peripheral vascular platform addressing significant clinical needs. IVL technology is experiencing strong growth as physicians increasingly adopt it for calcium modification in complex cardiovascular procedures. The transaction remains subject to customary closing conditions.
Stryker has raised $120 million in a Series C round led by Ribbit Capital, valuing the medical technology company at $1.45 billion. The funding comes despite shares declining 7.6% over the past six months, outperforming the industry's 19.7% drop. The company delivered 11% organic sales growth in Q4 2025 and 10.3% for the full year, marking its fourth consecutive year of double-digit growth. Performance was broad-based across its Orthopaedics, MedSurg and Neurotechnology segments, driven by strong procedural volumes and favourable demographics. Stryker achieved over 100 basis points of operating margin expansion for the second consecutive year despite tariff pressures. The company enters 2026 with a robust capital equipment backlog, though rising interest costs and tariffs present near-term challenges. Analysts maintain a Hold rating on the stock.
Stryker shares fell 9% to $339 following a destructive cyberattack by Iranian-linked group Handala that wiped over 200,000 systems and disrupted manufacturing and shipping operations across 56,000 employees in 61 countries. The medical technology company confirmed disruptions to order processing but stated there was no indication of ransomware. Unlike typical ransomware attacks, this wiper attack permanently deleted data rather than holding it for ransom, complicating recovery efforts. The incident threatens Stryker's 8% to 9.5% organic growth guidance for 2026 if operations fail to normalise quickly. Stryker generated $25 billion in revenue in 2025 with $4.283 billion in free cash flow and holds $4 billion in cash. Analysts maintain a consensus price target of $424.89 with 22 buy ratings and no sell ratings among 30 covering analysts.
Stryker reported Q4 revenues of $7.17 billion, up 11.4% year-over-year and exceeding analyst expectations by 0.8%. The medical device manufacturer, which impacts over 150 million patients annually through its orthopaedics, surgical tools, neurotechnology and patient care solutions, delivered what CEO Kevin Lobo called "an outstanding finish to 2025". The company achieved double-digit sales and adjusted earnings per share growth for both the quarter and full year, whilst expanding adjusted operating margin by at least 100 basis points for the second consecutive year. Across the medical devices and supplies sector, the six diversified stocks tracked reported mixed Q4 results. As a group, revenues beat consensus estimates by 1.9%, though share prices have declined an average of 5.1% since the latest earnings announcements.