Leading organization within systems engineering, risk management and design control including process improvement, best practices and tools for operational excellence.
Managing, mentoring, coaching and developing Systems Engineering team for individual career development consistently with organization strategy.
Collaborating with cross-functional teams, internal and external stakeholders to meet project objectives.
Defining and decomposing design inputs into systems, subsystems and interfaces to enable each applicable function to design, verify and validate the product.
Analyzing and comparing technological tradeoffs to enable cross-functional decisions including, for example, power budget, tolerance analysis, reliability analysis, error budget, design and supplier/component evaluations.
Analyzing system risks and identifying appropriate risk control measures.
Developing design verification and validation strategy in collaboration with functional owners to demonstrate that design outputs meet design inputs.
Completing Traceability Matrices demonstrating that Design Outputs meet Design Inputs with objective evidence, e.g., design verification or validation reports.
Identifying, investigating, planning, implementing and/or leading the disposition of defects, non-conformance investigation, Corrective Actions and Preventive Actions and/or Change Control.

Requirements

Systems Engineering (e.g., INCOSE certification or MBSE) – expert
Design Control Engineering and medical device product development process (e.g., ISO 13485 & 21 CFR 820.30) - good
Software development including agile methodologies and design for cybersecurity, e.g., IEC 62304, AAMI TIR45, agile software development, e.g., Scrum - some
Risk management (e.g., ISO 14971) including Usability risk (e.g., IEC 62366-1) - expert
Engineering/scientific analysis and appropriate tools
Requirement management and risk management tools
Preferred experience in active implantables for neuromodulation
Preferred experience in developing complex electro-mechanical-software systems.
Change Control, Non-Conformance, Corrective Action and Preventive Action

Benefits

Health benefits – Medical, Dental, Vision
Personal and Vacation Time
Retirement & Savings Plan (401K)
Employee Stock Purchase Plan
Training & Education Assistance
Bonus
Referral Program
Service Awards
Employee Recognition Program
Flexible Work Schedules

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

Systems EngineeringDesign Control EngineeringMedical device product developmentSoftware developmentAgile methodologiesRisk managementEngineering analysisRequirement managementChange ControlCorrective Action

Soft skills

LeadershipMentoringCoachingCollaborationProcess improvement

Certifications

INCOSE certificationMBSEISO 1348521 CFR 820.30ISO 14971IEC 62304AAMI TIR45IEC 62366-1