Senior Engineering Group Leader - System Engineering

Overview

Position Summary: Reporting to the Functional Manager, responsible for assigning and overseeing the practical use of technology across multiple programs assuring the proper use of common architecture. Receives requirements specifications from the Projec

UProgram Managers and prepares specifications to design, develop or integrate technologies required to make a product and its specific derivatives. Responsible for all Functional Specifications and Theory of Operation documents, including schematics, design layouts, detail and assembly drawings, bill of materials, associated analytical data and any implementation documents. May act as group leader or lead engineer on a major program, perform independent development, and be responsible for a number of smaller projects.

Skill Level and Background:

• System Experience(Platform Integration/Risk Management/V&V)
• Musthave abachelor’s degree in Electrical Engineering, Systems Engineering,Biomedical Engineeringor closely related field.
  
  Advanced degree is preferred
• Must have a proven track recordinamanagementor leadership rolewith ademonstratedrecordmanagingand/or developing systems engineeringteamcapability.(7-10yearsexperience)(team of5+ pplstrongly desired)
• Strong project engineering/managementcapability withexpertisein Waterfall and Agile methodologies. Proven ability to plan and deliver complex programs (resource allocations, workload balancing, WBS, PI planning) while leading and developing high performing team.
• Experience leading the development of test strategies, exploratory evaluations, and formal design verification from early concept through submission readiness.
• Must have experience in design requirements andrisk management, with the ability to translate identified and emerging risks into actionable verification strategies and detailed test plans, driving risk mitigation to closure in collaboration with cross-functional teams.
• Partner with Quality Engineering and Regulatoryteamsto support audit readiness and contribute to the Design History File (DHF)
• Shouldhave experience in estimating andplanverification and validation activities across the development lifecycle
• Specify detailed and traceable test cases based on system requirements and risk analysis
• Organize and lead defect review meetings with relevant team members. Providetimelyupdates on test progress, defect status, and overall V&V activities.
• Experience developing and executingcomprehensive system strategies for system integration, verification, and validation according to standard operating procedures and design controls.
• Understandscompliance concepts and testing requirements(IEC 60601) for Noise/EMI/EMCmitigation.
• Experience with risk management tools (e.g., JAMA, DOORS, Cockpit), with JAMA preferred.
• Musthave experience with
  
  Design Control & Risk Managementaccording to international standards (ISO-13485, ISO-14971) desired.
• Must befamiliarwith
  
  Human Factors & Usability Engineering

About your Leadership:

• Technical authority that helps guide the decision-making process for Coagulation programs
• Credible leader who can influence with strong organizational and prioritization skills with a results-oriented mindset
• Leads the definition of the instrument risk and V&V strategy driving alignment across cross-functional teams in R&D
• Leads with hands-onapproachin the development of design verification plans andauthoringprotocols that map requirements to objective test methods with defined acceptance criteria.
• Manages a team responsible for planning and execution of the integration strategy together with Mechanical Engineering, Electrical Engineering, Software Engineering, Systems Engineering,Coag Analytical, and Reagent Development
• Partner with the Project Manager to define the Design Control Schedule and resources (FTE, Instruments, Tools)
• Drives diverse technical team to find alternative solutions to manage through development and integration roadblocks
• Supports subsystem teams in managing complexity, interdependencies, modularity
• Leads the technical decision-making process to drive consensus amongst the core team for go, no-go, or redirect decisions in all phases of the project (concept, feasibility, development)
• Mentors junior engineers, and are available and engaged with the entire program team

Must Have:

• People Management (team greater than5people)
• Class II or III Medical device experience under IEC 60601, FDA
• Proven ability to effectively manage a team (Internal and External)
• Ability to communicate ideas and information clearly,effectivelyandfrequently
• Direct knowledge of regulatory requirements and industry standards in medical device industry
• Strong project and people management skills

Minimum Knowledge & Experience Required for the Position:

• Requires a B.S. in Engineering and at least 15 years of experience or an M.S. Degree and at least 10 years of experience in degreed field.
• Must have a demonstrated interest in managing a product development effort.

International Mobility:

Required:

• No

Travel requirements: