Full-Time

Staff Engineer

Design Quality

Posted on 11/1/2025

Stryker

Stryker

10,001+ employees

Manufactures orthopedic and surgical medical devices

Compensation Overview

$100.7k - $165.1k/yr

+ Bonus

Company Historically Provides H1B Sponsorship

Irvine, CA, USA

In Person

Category
QA & Testing (1)
Required Skills
Risk Management
Requirements
  • Bachelor’s degree in science, engineering or related discipline.
  • 4+ years’ related experience required.
  • Medical device industry experience required.
  • Familiarity with New Product Development (NPD) processes and/or involvement in cross-functional activities supporting product development and commercialization.
Responsibilities
  • Develop quality documentation to support new product development and regulatory submissions.
  • Maintain and improve quality systems by identifying procedural deficiencies.
  • Lead risk management activities and present final risk/benefit justifications to leadership.
  • Drive product and process design activities in cross-functional teams.
  • Define and validate design verification and validation (V&V) test requirements and methods.
  • Present product risks during design reviews and ensure mitigation through development.
  • Support manufacturing process development and product design transfer to internal/external sites.
  • Apply statistical analysis and problem-solving techniques to define acceptance criteria and resolve quality issues.
  • Review and approve inspection plans, routers, and product drawings.
  • Evaluate predicate devices and define critical quality attributes through risk analysis.
  • Contribute to final V&V reports with statistically valid conclusions and graphical summaries.
  • Support early market feedback collection and resolution of initial product concerns.
Desired Qualifications
  • MS, CQE, or CRE preferred.
  • Six Sigma Green or Black belts are preferred.
  • Experience with the medical device development lifecycle, including risk management and design/process verification and validation.
  • Proficient in quality tools such as FMEA, GD&T, root cause analysis, and Poka-Yoke, as well as core quality concepts.
  • Proficient in data analysis tools (e.g., Minitab) and interpreting CAD drawings to support design and process evaluations.
  • Proven project management and cross-functional collaboration skills.
  • Excellent communication, problem-solving, and analytical abilities.

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 Jobs

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

ASC News
Apr 13th, 2026
ASC Technology Roundup: Distalmotion Files for Expanded Robotic Gynecology Clearance; Stryker, Medtronic Make Acquisitions

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…

Market Wire News
Apr 13th, 2026
Stryker to acquire Amplitude Vascular Systems, adding next-gen IVL tech to peripheral vascular portfolio

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.

Yahoo Finance
Mar 18th, 2026
Stryker posts 11% Q4 growth amid tariff pressures, margin expansion continues

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.

Yahoo Finance
Mar 13th, 2026
Stryker shares fall 9% to $339 after Iranian cyberattack wipes 200,000+ systems

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.

Yahoo Finance
Mar 12th, 2026
Stryker reports 11.4% revenue growth in Q4, beating estimates with $7.17B

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.

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