Lead Systems Engineer

Planet Pharma; Hazelwood (MO); On-site; USD 140,000 - 190,000; Full time

Job summary

Planet Pharma is seeking a senior Systems Engineer to provide technical leadership for the development of complex medical device systems and disposables. This role coordinates system development across software, hardware, design control, and product validation, collaborating with microbiology and chemistry teams to ensure integrated solutions.

The ideal candidate has a Bachelor in engineering or science, 10 years in complex hardware/software systems, and experience with FDA regulatory

Qualifications

• Strong written communication skills for technical data
• Understanding across engineering disciplines and supporting functions
• Experience aligning development activities with FDA/regulatory expectations

Responsibilities

• Accountable for system engineering aspects of R&D projects with focus on integration and proper documentation
• Own System Product Requirements and System Architecture
• Contribute to System Risk Analysis, Interface Design, and Verification & Validation planning
• Lead or coordinate complex technical activities and provide recommendations on technical and budgetary decisions
• Coordinate technical reviews with internal experts or external partners
• Ensure System Development readiness for major milestones
• Foster communication with Project Managers, QA, Manufacturing Eng., and other teams
• Align development activities with microbiology and chemistry functions and external partners
• Advise management on task prioritization and execution
• Track and report project status to stakeholders
• Ensure compliance with company quality procedures and standards
• Perform other duties as assigned

Skills

Written communication

Cross-department knowledge

Metrics/KPIs

Ethics and integrity

Problem solving

Education

Bachelor degree in engineering or science

MS preferred

Job description

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 companypromotes.

• 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.