Principal Design Quality Engineer - Digital (Remote) at Stryker

New Jersey, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree in science or engineering required; preferred in Software Engineering, Computer Science, Electrical Engineering, System Engineering, Product Security, or mathematics
Minimum 8 years of related experience, including at least 4 years in new product development or software/systems quality engineering activities within a highly regulated environment
Demonstrated knowledge of security control frameworks, risk assessments, and threat scoring
Flexibility to work across multiple time zones (collaborating with global teams, including Europe and India); preferred locations CST or EST; proximity to Columbia City, IN, or Memphis, TN is a plus but not required
Preferred
Master’s degree in a related field
Experience with security risk management processes in healthcare or medical devices
Familiarity with programming languages, embedded software tools, and Agile methodology
Direct experience in vulnerability management and defect review
One or more active, industry-recognized cybersecurity certifications
Understanding of NIST, ISO, and related security frameworks, particularly in vulnerability management
Knowledge of medical device regulations (e.g., US FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, FDA cybersecurity guidance)

Responsibilities

Provide design controls expertise throughout product development, ensuring successful design transfer
Develop and implement risk management strategies for product and cybersecurity to safeguard patient safety
Interpret and apply industry standards and regulations to establish world-class quality processes
Lead and mentor teams to build robust software architecture aligned with regulatory requirements
Drive development and utilization of tools and systems that enhance product and process performance
Facilitate internal and external audits to maintain compliance with global quality standards
Guide product development teams through vulnerability assessments within defined security risk frameworks
Communicate security initiatives and process improvements to leadership and stakeholders across global teams

Skills

Key technologies and capabilities for this role

Design ControlsRisk ManagementCybersecuritySoftware ArchitectureRegulatory ComplianceQuality EngineeringVulnerability AssessmentsAuditsProduct Security

Questions & Answers

Common questions about this position

What is the salary range for this Principal Design Quality Engineer role?

The salary range is $115,600.00 to $245,800.00 plus bonus eligible + benefits. Actual minimum and maximum may vary based on location, with individual pay based on skills, experience, and other relevant factors.

Is this position remote, and what are the location preferences?

The role offers work flexibility: Remote or Hybrid or Onsite. Preferred locations are CST or EST; proximity to Columbia City, IN, or Memphis, TN is a plus but not required, with flexibility to work across multiple time zones essential due to global teams.

What are the required qualifications and skills for this role?

A Bachelor’s degree in science or engineering is required, preferably in Software Engineering, Computer Science, Electrical Engineering, System Engineering, Product Security, or mathematics, with minimum 8 years of related experience including at least 4 years in new product development or software/systems quality engineering in a highly regulated environment, and demonstrated knowledge of security control frameworks, risk assessments, and threat scoring.

What travel is required for this position?

Travel is required up to 10%.

What experience makes a candidate stand out for this role?

Preferred qualifications include a Master’s degree, experience with security risk management in healthcare or medical devices, familiarity with programming languages, embedded software tools, and Agile methodology, direct experience in vulnerability management and defect review, active cybersecurity certifications, and knowledge of NIST, ISO, medical device regulations like FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, and FDA cybersecurity guidance.

Stryker

Develops and manufactures medical devices and equipment

About Stryker

Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.

Kalamazoo, MichiganHeadquarters

1941Year Founded

$423.3MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

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

Risks

Integration challenges from acquisitions may strain Stryker's resources.

Rapid tech advancements risk obsolescence of Stryker's current products.

Regulatory scrutiny on acquisitions could delay Stryker's market entry.

Differentiation

Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.

Entry into the peripheral vascular segment diversifies Stryker's market presence.

Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.

Upsides

Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.

The orthopedic implants market growth benefits Stryker's expanding product line.

Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.

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