Industrial Engineer

Medical Engineering Consultants (MEC); Ocala (FL); On-site; USD 70,000 - 110,000; Full time

Job summary

Medical Engineering Consultants (MEC) seeks an Industrial Engineer for contract to hire in Ocala, FL. The role focuses on process controls, design transfer, and NPD support within a regulated medical-device environment.

On-site collaboration with Product Development, Quality, and Manufacturing teams is essential to drive remediation and scalable improvements. The ideal candidate will have 3+ years in medical devices, strong Lean Six Sigma experience, and a track record of coordinating

Qualifications

• Bachelor's degree in Engineering or technical field.
• 3+ years experience in medical device industry, preferably with orthopedic implants or similar devices.
• Strong knowledge of Production and Process Controls, including process validation and documentation across full life cycle.
• Experience supporting New Product Development, Design Transfer, DFM, and manufacturability assessments.
• Experience relating to FDA warning letters and 483 observations remediation.

Responsibilities

• Support NPD and Production & Process Controls projects as a Process Controls resource.
• Partner with Product Development teams during design and development with Design Transfer focus.
• Assess current state manufacturing and identify process improvements using Lean Six Sigma and other IE methods.
• Support Design for Manufacturability and scalable designs.
• Collaborate with suppliers and internal teams to ensure manufacturable designs.

Skills

Lean Six Sigma

Kaizen

Project management

Cross-functional teamwork

Process optimization

Education

Bachelor's degree in Engineering

Tools

Process Validation tools

Documentation systems

Job description

Job 2878 - Industrial Engineer - Contract located in Ocala, Florida

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill‑set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

This could be a Contract to Hite role.

Background

• The client is a global medical device company based in based northern Florida specializing in orthopedic implants, including hips, knees, shoulders, ankles, and related surgical instruments.
• The client is conducting multiple separate efforts simultaneously to address a range of issues from a previous FDA warning letter and additional recent FDA 483s, including process validation, design and development file remediation, Device Master Record remediation, and supplier file remediation
• The client is also continuing new product development and will be conducting Design Transfer activities.
• As a result of the remediation activities, processes may not be as efficient or scalable as needed for future growth.
• The client is seeking resources with comprehensive experience in process controls, including an understanding of the full product life cycle, and industrial engineering experience to drive operational efficiency.

Key Responsibilities

• Support New Product Development (NPD) projects and Production & Process Controls (P&PC) projects as a Process Controls resource.
• Partner closely with Product Development (PD) teams throughout design and development phases, with a focus on Design Transfer requirements.
• Conduct assessments of current state manufacturing and identify process improvements using Lean Six Sigma and other industrial engineering methodologies.
• Support Design for Manufacturability (DFM) activities.
• Collaborate with suppliers and internal teams to ensure manufacturable, scalable designs.

Qualifications

• Bachelor’s degree in Engineering or Technical Field
• 3+ years experience in the medical device industry, preferably with orthopedic implants, surgical instruments, or similarly regulated Class II/III devices.
• Strong working knowledge of Production and Process Controls, including process validation, manufacturing process development, and documentation requirements across the full product life cycle.
• Demonstrated experience supporting New Product Development, Design Transfer, Design for Manufacturability, and manufacturability/scalability assessments.
• Experience supporting remediation activities related to FDA warning letters, FDA 483 observations, design and development files, Device Master Records, supplier files, or process validation deliverables.
• Industrial engineering and operational excellence experience, including the ability to assess current-state manufacturing processes and identify scalable improvements using Lean Six Sigma, Kaizen, or similar methodologies.
• Ability to partner effectively with Product Development, Quality, Manufacturing, Regulatory, suppliers, and cross-functional technical teams in a fast-paced remediation and product development environment.
• Strong project execution, facilitation, and communication skills, including the ability to coach teams on disciplined execution of medical device deliverables and quality system expectations.
• Availability to work on-site in northern Florida; contract-to-hire interest.

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position

Check us out at www.medicalengineeringconsultants.com

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.