LEAD SYSTEMS ENGINEER

Planet Pharma; Hazelwood (MO); On-site; USD 120,000 - 160,000; Full time

Job summary

Planet Pharma in Hazelwood, Missouri is seeking a Lead Systems Engineer to provide technical leadership for the development of complex medical device systems and disposables, coordinating across software, hardware, design control, and external partners.

You will own system requirements, architecture, risk analysis, verification planning, and ensure milestones. Requires a Bachelor's degree and 10 years' related experience plus FDA familiarity.

Qualifications

• Bachelor degree in engineering or scientific discipline.
• 10 years of professional experience in complex hardware/software/biology systems with FDA experience.
• Experience with FDA regulatory requirements.

Responsibilities

• Lead system development across hardware, software, integration, and design control.
• Coordinate system development with microbiology and chemistry functions and external partners.
• Own System Product Requirements and System Architecture.
• Lead or coordinate complex technical activities and risk analysis.
• Communicate project status and ensure readiness for milestones.
• Ensure compliance with company quality procedures and standards.

Skills

System leadership

Cross-functional coordination

Design control

Education

Bachelor degree in engineering or science

MS preferred (Systems/Biomedical)

Job description

Lead Systems Engineer

Location: Hazelwood, Missouri

Category: Engineering

Salary: Apply for details

Country: United States

Employment: Direct Hire/Perm

Worksite: On-Site

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

• 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.
• Accountable for System Product Requirements and System Architecture.
• Strong contributor to System Risk Analysis, System Interface Design, and System Verification and Validation Planning.
• Leads or coordinates complex technical activities and investigations and provides recommendations regarding technical and budgetary decisions.
• Coordinates technical reviews with internal business experts within the organization or with external experts and development partners.
• 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.
• Ensures System Development readiness for major project milestones.
• Fosters strong communication with Project Managers, Program Managers, Functional Managers, Technical Leads, Quality Assurance, Manufacturing Engineering, and other internal and external project team representatives.
• 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.
• Performs recommendations to management regarding project task prioritization and execution.
• Tracks and reports project status to various stakeholders.
• Performs all work in compliance with company quality procedures and standards.
• Performs other duties as assigned.

Qualifications

• 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 company 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.

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.