Manufacturing Engineer - Medical Device

We are seeking an experienced Manufacturing Engineer with a strong background in medical device production to join our dynamic manufacturing team. This role requires a versatile professional who can manage multiple complex projects while ensuring compliance with stringent medical device industry standards and regulations. The ideal candidate will have 5+ years of experience in medical device manufacturing, demonstrating improved manufacturing methods, systems, and processes to produce a high‑quality product.

Responsibilities

• Lead manufacturing process development and validation activities, including engineering protocols, IQ, OQ, PQ reports, bill of materials, assembling instructions, manufacturing instructions, and procedures.
• Troubleshoot and optimize manufacturing processes for medical devices to ensure efficient production while maintaining quality standards.
• Write, review, and maintain manufacturing procedures, work instructions, Standard Operating Procedures (SOPs), and process specifications in compliance with FDA regulations and ISO 13485.
• Design, develop, and implement manufacturing fixtures, tooling, and equipment for production of medical devices, ensuring proper functionality and compliance with design controls.
• Lead root cause analysis investigations, implement corrective and preventive actions (CAPA), and drive continuous improvement initiatives to enhance product quality, reduce waste, and improve manufacturing efficiency.
• Collaborate closely with Quality Assurance, R&D, and Production teams to ensure seamless product launches.
• Perform other duties and projects as assigned.

Qualifications

• Education: Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field.
• Experience: Minimum 5+ years of experience in medical device manufacturing engineering; proven experience with medical devices (metal‑based components, assemblies, and processing preferred).
• Technical Skills: Proficiency in CAD software (SolidWorks, AutoCAD, or similar); knowledge of statistical process control (SPC) and lean manufacturing; understanding of medical device validation processes (Installation Qualification, Operational Qualification, Performance Qualification).
• Regulatory Knowledge: Thorough understanding of ISO 13485:2016 Medical Device Quality Management System and FDA regulations.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan with Company Match
• Paid Time Off, Personal Days, and Birthday Holiday
• Lifetime Membership Subsidy and Wellness Resources
• Life Insurance (Basic, Voluntary & AD&D)
• Family Leave (Maternity, Paternity)
• Short‑Term & Long‑Term Disability
• Taco Thursdays!