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Stryker.

Staff Engineer, System Design

Stryker. - Fort Lauderdale, FL

About Stryker

Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. All 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.

Job Description / Information

Optimize systems engineering capabilities using knowledge from standard industry practices and regulatory standards

Provide solutions for improvement of established system design & test development methods

Responsible for system projects/features in terms of leading cross-function design & integration, flow-down of the documentation (requirements, specifications, protocols, use cases) and planning and conducting integration steps (analysis & tests)

Apply systems modeling language/tools (Sys ML) to define architecture, behavior, state, data flow, context view and interface description to assist with design and integrations activities.

As subject matter expert of the MAKOplasty applications, provide technical oversight for the analysis, development, verification and validation of products

Provide technical guidance and mentorship to team members

Manage the technical product development activities to ensure timely completion of projects

Through sound engineering problem-solving techniques, manage and resolve system field issues reported through the complaint process

Support the engineers during risk assessments and root cause investigations to meet the company metrics for timely handling of complaints and CAPA activities

Lead and provide technical expertise for the creation of risk management documents (AFMEA, FTA, FMECA).

Coordinate with program management to establish project scopes, resources needs, priorities and schedules.

Drive the growth of the team by supporting the recruitment of top performing talents in collaboration with the Manager of System Design

Develop expert knowledge of regulatory standards applicable to medical device and software development life cycle: 21 CFR part 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601

Develop expert knowledge of systems engineering principles based on industry practices and guidance from organizations such as INCOSE

Provide mentorship to the engineers with regards to regulatory standards and application of Stryker’s quality procedures.

Oversee system level verification and validation activities including definition of test strategies, development and validation of test methods, execution of protocols, data collection and documentation

Identify and plan mitigation strategies for project and technical risk.

Manage technical feature risk retirement activities including analyses, prototyping and feasibility activities

Develop a strong understanding of the clinical application of Stryker’s robotic solutions and product line

Solicit and incorporate the input from surgeons, engineering, sales, marketing, quality assurance and operations to MAKO’s product lines

Ensure correctness of documents produced by the team members

Convey project status to management and team members as needed.

Articulate issues and make recommendations for improvement to program and executive management as appropriate.

Minimum Qualifications

Minimum bachelor’s degree in an engineering discipline, with Systems Engineering specialization as plus, and with at least 6 years of experience

Minimum of 3 years of experience in a leadership position

Experience in system of systems with background in medical devices & imaging, robotics, aerospace and/or automotive

Proficient with systems engineering principles and systems modeling tools

Experience in software development life cycle processes and AGILE is a plus

Ability to accurately set and meet dates/times for issue resolutions or updates

Keen sense of teamwork is highly essential

Must be extremely detail oriented with strong written, verbal, interpersonal, computer, and organizational skills

Must have excellent oral, written and interpersonal communication skills

Must be able and flexible to work well under changing priorities in a high energy and demanding environment.

Strong knowledge of regulatory standards and quality processes

Strong leadership, interpersonal, organizational and problem solving skill

Strong creative thinking skills

Good customer service and presentation skills

10 days 13 hours ago

Stryker.

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Staff Engineer, System Design Stryker. - Fort Lauderdale, FL, United States

   

Location: Fort Lauderdale, FL

Company Profile:
Stryker is one of the world's leading medical technology companies and, together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.