Lead System Engineer

 

Position Summary

This is an open research functional position with an emphasis on technical leadership for the development of complex medical device systems and associated disposables both internally and with external development partners. This individual will coordinate all system development activities across multiple engineering disciplines and functions by applying various methods, tools, and techniques to achieve successful product development outcomes. This includes integration and coordination of all system development functions (software engineering, hardware engineering, integration, design control and product validation) as well as integration and coordination with the deliverables of the microbiology and chemistry functions.

 

Primary Duties

1. Is accountable for the technical engineering aspects of R&D projects assuring proper documentation, respect of good scientific, quality and safety procedures, with a focus on system integration.

2. Accountable for System Product Requirements and System Architecture.

3. Strong contributor to System Risk Analysis, System Interface Design, and System Verification and Validation Planning.

4. Leads or coordinates complex technical activities and investigations and provides recommendations regarding technical and budgetary decisions.

5. Coordinates technical reviews with internal business experts within the organization or with external experts and development partners.

6. Ensures System Development team on the assigned project(s) team communicating pertinent information back to the functions as well as communicating any technical issues at the project level as needed.

7. Ensures System Development readiness for major project milestones.

8. Fosters strong communication with Project Managers, Program Managers, Functional Managers, Technical Leads, Quality Assurance, Manufacturing Engineering, and other internal and external project team representatives.

9. Ensures alignment of development activities across System Development, microbiology, and chemistry functions and external development partners (when applicable) such that planning and execution are synchronized within the team as well as with the needs of the project.

10. Performs recommendations to management regarding project task prioritization and execution.

11. Tracks and reports project status to various stakeholders.

12. Performs all work in compliance with company quality procedures and standards.

13. Performs other duties as assigned.

 

Qualifications

Required Education, Training and Experience

• Bachelor degree required in an engineering or scientific discipline 

• 10 years of professional related experience in complex systems of hardware, software, or biology and Experience with FDA regulatory requirements. 

Preferred Education, Training and Experience

• MS Preferred 

• Systems Engineering or Biomedical Engineering Preferred

• Demonstrated experience in the design of complex medical (or equivalent) device systems with focus on minimizing timelines and maximizing development efficiencies.

• Possesses strong planning and negotiation skills.

• Self-motivated and self-directed with the ability to schedule and work with little supervision.

 

Knowledge, Skills, and Abilities

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.

• Cross-department knowledge about the roles, responsibilities, goals, and processes of different departments within an organization.

• Written communication – including the ability to communicate technical data in written form.

• Solution-oriented in the face of conflict. Demonstrates assertiveness and confidence in the face of a challenge.

• Managing and measuring work by tracking progress, performance, and goal achievement using metrics and KPIs.

 

Working Conditions and Physical Requirements 

Typical office and lab  setting. Requires ability to remain stationary for prolonged periods. Domestic travel: 5% International travel: 5% Total travel: 10%

The estimated salary range for this role is between $150,000-$205,000. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful ca