Principal Systems Engineer/Technical Lead (Medical Devices)

Jabil Circuit; Tampa (FL); On-site; USD 100,000 - 125,000; Full time

Job summary

An established industry player is seeking a System Engineer to lead technical product development for innovative medical devices. This role involves overseeing project execution, ensuring compliance with industry standards, and collaborating with cross-functional teams to drive successful outcomes. The ideal candidate will possess a strong technical background, excellent communication skills, and a proven track record in managing complex projects. Join a dynamic environment where your leadership will contribute to the development of cutting-edge medical solutions that enhance patient care and meet customer expectations.

Qualifications

• Bachelor's degree in Biomedical Engineering or related field required.
• 10+ years of experience in medical device development needed.

Responsibilities

• Lead project planning with timelines and milestones.
• Ensure compliance with project specifications and industry standards.
• Coordinate stakeholder communication and manage project risks.

Skills

Technical background

Project management methodologies

Communication skills

Analytical skills

Problem-solving abilities

Attention to detail

Leadership skills

Critical thinking

Knowledge of medical device standards

Education

Bachelor's degree in Biomedical Engineering

10+ years of relevant experience

Job description

Overview

The System Engineer will be the technical leader of a cross-functional team for the development of new medical devices developed in conjunction with our customer partners in a fast-paced environment.

The technical lead will be responsible for overseeing all technical aspects of a project, including planning, directing resources, and ensuring quality control throughout the project lifecycle, while working closely with a project manager to deliver the project on time and within budget while adhering to technical specifications and standards. Duties will include planning and hosting technical and formal design reviews, leading problem-solving initiatives, coordinating with stakeholders to ensure all technical elements of the project are accounted for and ensuring project deliverables meet technical requirements and customer expectations. Overall responsibility for technical direction, execution, and outcome. The ideal candidate will have a successful track record of leading technical product development teams and launching products into production.

Location

This role will be based on-site at our St. Petersburg, FL - JIC facility (office/testing lab environment). This is not a remote role.

Job Responsibilities

• Project planning: Work with the project manager to develop project plans, timelines, milestones.
• Technical design review: Analyze and approve engineering designs to ensure compliance with project specifications and industry standards.
• Prototype oversight: Monitor prototype build activities to verify adherence to build plans and the ability for the design to be manufactured to meet specifications.
• Problem-solving & Root Cause Analysis: Identify and resolve technical issues that arise during project execution following appropriate problem-solving methodologies (8D, 3A, Ishikawa, 5-whys, etc.).
• Stakeholder communication: Coordinate with customers, suppliers, NPI sites, and other project team members to keep everyone informed of technical progress and concerns.
• Cost management: Be conscious of how design decisions impact project NRE and final product cost.
• Cross-functional engagement: Ensure all functions are supported through effective collaboration and engagement.
• Quality control: Ensure project deliverables meet required standards.
• Risk and opportunity management: Identify potential project/technical risks and develop mitigation strategies. Identify areas of opportunity to enhance the customer experience.
• Reporting: Prepare and provide status updates for stakeholders (customer, business unit, and internal management), including progress updates, challenges, and corrective actions.
• Concept Development including evaluation and selection.
• Oversee HW/SW integration.
• Work with product verification team for test method development and execution.
• Participate in prototype build activities.
• Ensure the needs and expectations of the customer are universally communicated and met.

Required Skills

• Strong technical background.
• Proficiency in project management methodologies.
• Excellent communication and interpersonal skills to effectively collaborate with diverse teams.
• Analytical and problem-solving abilities to address technical challenges.
• Attention to detail and ability to work under pressure to meet deadlines.
• Leadership skills to guide the team and represent the team.
• Solid critical thinking and decision-making skills.
• Ability to work closely with the project manager and drive action within the team.
• Clearly communicate complex information especially with the management team.
• Knowledge of the medical device standards and regulations such as IEC 60601.

Education and Work History Requirements

• Bachelor's degree in Biomedical Engineering or related field is required.
• At least 10+ years of relevant experience in medical device development.
• Experience managing entire design cycles from concept-to-production.
• Or an equivalent combination of experience, education, and/or training.