Senior Staff R&D Engineer - Systems

Stryker Corporation; Waltham (MA); On-site; USD 123,000 - 205,000; Full time

Job summary

Stryker Corporation in Waltham, MA, is seeking a Senior Staff R&D Engineer to provide system-level technical leadership throughout the lifecycle of medical devices, focusing on commercialization and sustaining engineering.

You will mentor others, manage design changes, verify safety requirements, and collaborate across engineering, quality, manufacturing, regulatory and operations to ensure safe, reliable products for customers.

Qualifications

• Bachelor’s degree in engineering (Systems/Biomedical/Mechanical/Electrical/Software).
• At least 6 years in a regulated industry.
• Experience with product development, system integration or lifecycle activities.

Responsibilities

• Lead system-level engineering for commercial medical devices.
• Lead reliability assessments to understand performance and improve longevity.
• Investigate product issues using data from field, service, manufacturing, reliability and complaints.
• Define, maintain and refine system requirements, architectures and interfaces.
• Allocate requirements across electrical, mechanical and software subsystems.
• Lead risk management activities and verify safety requirements.
• Lead and support system integration, reliability, regression and verification testing.
• Mentor engineers on systems engineering methods and design controls.

Skills

Systems Eng

Leadership

Reliability Analysis

Risk Management

SysML/MBSE

Jama

Regulatory Knowledge

Cross-functional

Education

Bachelor's degree in Engineering

Tools

Jama

SysML

Job description

Work Flexibility: Onsite

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 to find the pay range for your location.

Travel Percentage: 20%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility

Remote - Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location.

Field-based - You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based.

Onsite - Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category.

Hybrid - You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.