Prin Hardware System Engineer

Responsibilities Include:

• As tech lead, guide collaboration amongst sub-system owners to prioritize tasks and bring the functional design interfaces together
• Drive sub-system development workstreams to deliver commitments against timelines and budget.
• Strong understanding of Polarion, or similar software, to own documenting technical inputs and design output matrix and artifacts for traceability.
• Strong understanding of system-wide product design, being accountable to deliver technical solutions that meet clinical and non-clinical needs, in collaboration with the Product Owner.
• Responsible for completing systems engineering activities to translate concepts into fully functional and tested products.
• Deep knowledge of standards (IEC 60601, ISO 62304, ANSI C63.27, etc.); accountable for identification of applicable standards and clauses necessary for a product and delegation of functions responsible for executing testing and producing testing reports.
• Capture and review schematics, PCBA layouts, and component selection.
• Work with 3D CAD assemblies and models within larger system builds.
• Engage design enhancement exercises to optimize costs, complexity, and manufacturing time.
• Conduct test and validation procedures to ensure the products function correctly and safely (including designs with patient applied parts), along with contracting through certified test houses.
• Collaborate closely with software, mechanical, electrical, and manufacturing teams to deliver integrated system solutions.
• Manage external design/manufacturing partner projects and relationships as an integral function of system design and strategy.
• Track progress, risks, and findings across functional sub-systems, organizing formal and informal technical documentation.
• Effectuate stage-gating processes for projects within the medical device product lifecycle
• Collaborate with broader organization-enabled initiatives on connectivity and AI to craft high-quality products and services that customers love and solve business challenges.
• Collaborate with other leaders to ensure successful development, manufacturing, release, and launch of world-class product (portfolio/program).

Must Have: Minimum Qualifications

• 7+ years' experience in the medical device industry in systems, digital or software development with proven record of accomplishment.
• Knowledge of Agile methodology is nice to have.
• Experience in 3+ system-level product or portfolio releases.
• Experience in a regulated product industry is nice to have.
• Ability to quickly understand complex system behaviors, engineering problems, technical and architectural constraints (electrical hardware, mechanical systems, software development and system integration, etc.)
• A robust design portfolio articulating past design work.
• Excellent verbal and written and communication skills with an aptitude for convincing others, both internally and externally, of the value of their ideas.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.