Senior Engineering Group Leader - System Engineering

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 requirement specifications from Program 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, detailed 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.

The annual base salary range for this role is currently $160,000 to $190,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401(k) plan retirement benefits with employer match, as well as paid vacation and sick leave.

Skill Level and Background

• Must have a bachelor's degree in Electrical Engineering, Systems Engineering, Biomedical Engineering or closely related field. Advanced degree is preferred.
• Must have a proven track record in a management or leadership role with a demonstrated record managing and/or developing systems engineering team capability (7-10 years experience, team of 5+ people strongly desired).
• Strong project engineering/management capability with expertise in Waterfall and Agile methodologies. Proven ability to plan and deliver complex programs (resource allocations, workload balancing, WBS, PI planning) while leading and developing a 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 and risk 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 Regulatory teams to support audit readiness and contribute to the Design History File (DHF).
• Should have experience in estimating and planning verification 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. Provide timely updates on test progress, defect status, and overall V&V activities.
• Experience developing and executing comprehensive system strategies for system integration, verification, and validation according to standard operating procedures and design controls.
• Understands compliance concepts and testing requirements (IEC 60601) for Noise/EMI/EMC mitigation.
• Experience with risk management tools (e.g., JAMA, DOORS, Cockpit), with JAMA preferred.
• Must have experience with Design Control & Risk Management according to international standards (ISO‑13485, ISO‑14971) desired.
• Must be familiar with 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 a hands‑on approach in the development of design verification plans and authoring protocols 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…