Industrial Engineer

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.