Job Description

Mammotome associates know that every moment matters when it comes to cancer diagnostics. When we come to work, were helping develop solutions that enable accurate diagnoses to turn anxiety into answers. If you are a Senior Systems Engineer with Medical Device experience who is passionate about improving Cancer Diagnostics than this may be the role for you!

Senior Systems Engineers are responsible for aspects of complex projects related to product design and development, with focus on customer needs, system requirements, architecture and design. Systems Engineers execute specific and general assignments that provide innovative, functional, cost effective and validated product designs.

Responsibilities we will trust you with:

* Collaborates with cross functional project teams to define user needs, interpret customer and marketing input to generate customer needs, technical system and subsystem level design requirements, rationales and develop detail designs.

* Applies knowledge of general engineering principles, materials, DFMA and reliability to achieve product design requirements.

* Develops and maintains requirements trace matrices including low-level mechanical, electrical, software requirements and design specifications.

* Key contributor with engineering teams to plan / de-risk remaining development work, taking into account key device interactions and interfaces.

* Performs design analysis on system and subsystem architecture, requirements and functional flow/operation.

* Works with team members on design elements (e.g., hardware/software and subsystem interface requirements, software requirements, risk mitigation, electrical and electro-mechanical safety, and user interface design).

* Supports product risk management activities with identification of use errors, and other known issues.

* Owns the project usability engineering file and is responsible for formative and summative usability studies per the requirements of IEC 62366 and FDAs Human Factors studies to improve customer interfacing of products by direct analysis of impact through risk evaluation and prioritization of use errors

* Supports development of product throughout design verification and validation plans and testing.

* Provides innovative product, system and component design solutions and coordinates integration of complex sub-system product designs.

* Participates or leads Design Phase Reviews.

* Own applicable corporate quality policies and drive updates based on new standards or regulations for compliance, and/or process improvements for efficient use of QMS.

* Provides guidance and mentorship to less experienced team members in all aspects of design execution.

* Strong understanding of global standards and regulations including but not limited to FDA and ISO and labeling, packaging, and electrical (60601).

Your areas of knowledge and expertise that matter most for this role:

* Bachelor degree (BS) in Engineering (e.g. Systems, Mechanical, Electrical, Software, Biomedical, Computer Science, or other related field); Advanced degree in field is desirable but not required.

* Minimum of 7 years related work experience is required.

* Experience in the medical device industry (manufacturing and/or engineering) required.

* Comprehensive understanding of FDA regulations (21 CFR Part 820) and ISO 13485 required.

* Professional certifications (i.e., CQE) desirable

* Experience with JAMA, DOORS or similar requirements management tools is preferred

Check out our benefits here: https://danaherbenefitsinfo.com/

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a pageDiversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

This job description in no way states or implies that these are the only duties to be performed by this employee. The incumbent is expected to perform other duties necessary for the effective operation of the department or unit. This job description may be changed at any time

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Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.