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Senior Staff R&D Engineer - Systems

Stryker

Waltham, MAJob$123–205K/yrSeen 1w agoSeen in employer's feed 2 days ago

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At a glance

Compensation
$123–205K/yr
Location
Waltham, MA
Work Authorization
Not specified

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Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

Stryker’s Amplitude Vascular Systems team seeks a Senior Staff R&D Engineer to provide system-level technical leadership across the lifecycle of medical devices, with a focus on commercialization and sustaining engineering. The engineer will investigate complex product issues and collaborate across engineering, quality, manufacturing, regulatory, service, and operations. The role supports a newly integrated business as it advances toward commercialization.

Skills & qualifications

RequiredNice to have

Skills

Product DevelopmentSystem IntegrationProduct Lifecycle ManagementPost-Commercialization Medical DevicesMechanical EngineeringMultidisciplinary SystemsRequirements ManagementJamaSysMLModel-Based Systems EngineeringISO 13485ISO 14971IEC 60601-1Medical Device Design ControlsReliability EngineeringFault Tree AnalysisFMEAStatistical AnalysisStructured Problem-Solving

Qualifications

Bachelor's in Engineering or Related6+ Years Engineering Experience in Regulated Industry5+ Years Medical Device Post-Commercialization Experience

Benefits

Medical Insurance
Dental Insurance
Vision Insurance
401(k) Match

Full job description

Join Stryker’s Amplitude Vascular Systems (AVS) team in Waltham , Massachusetts as a Senior Staff R&D Engineer . In this role, you will provide system-level technical leadership throughout the lifecycle of medical devices, with a focus on commercialization and sustaining engineering, investigate complex product issues, and partner across engineering, quality, manufacturing, regulatory, service, and operations functions to help ensure products remain safe, reliable, compliant, and available to customers.

This role offers a unique opportunity to support a newly integrated business as it advances toward commercialization.

What You Will Do

  • Lead system-level engineering activities for commercial medical devices, including design changes, product evaluations, and lifecycle management.

  • Lead reliability assessments and analysis to understand product performance, failure modes, and opportunities to improve product reliability and longevity.

  • Investigate product performance issues using field, service, manufacturing, reliability, and complaint data to identify root causes and improvement opportunities.

  • Define, maintain, and refine system requirements, architectures, interfaces, and technical documentation.

  • Allocate and decompose system requirements across electrical, mechanical, and software subsystems.

  • Lead risk management activities, including hazard identification, risk analysis, mitigation planning, and verification of safety requirements.

  • Lead and support system integration, reliability, regression, and verification testing associated with product changes.

  • Drive resolution of complex design, manufacturing, and service-related technical issues through structured engineering analysis.

  • Mentor engineers and provide technical guidance on systems engineering methods, design controls, industry standards, and engineering best practices.

What You Will Need

Required Qualifications

  • Bachelor’s degree in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Software Engineering, or related engineering discipline.

  • Minimum 6 years of engineering experience in a regulated industry.

  • Experience supporting product development, system integration, design changes, or product lifecycle activities.

Preferred Qualifications

  • Minimum 5 years of experience supporting medical devices in a post-commercialization environment.

  • Strong mechanical engineering foundation with experience working across multidisciplinary systems, including exposure to electrical and/or software components.

  • Experience with requirements management tools, including Jama.

  • Experience with SysML and model-based systems engineering (MBSE) methodologies and tools.

  • Knowledge of ISO 13485, ISO 14971, IEC 60601-1, and medical device design control requirements.

  • Experience with reliability engineering, fault tree analysis, FMEA, statistical analysis, and structured problem-solving methodologies.

US20 : $123,100 - $205,200 USD Annual

View the U.S. work location and transparency guide (https://view.stryker.com/viewer/fcd609f31e39eac44598615224ec7216?iid=69deda99678eb495e0710914#1) to find the pay range for your location.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

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