Senior Manufacturing Engineer

Harba; Indianapolis (IN); On-site; USD 80,000 - 100,000; Full time

Job summary

Harba in Indianapolis seeks a Manufacturing Engineer to lead new product introduction (NPI) activities and ensure compliance with regulatory standards. The role involves collaboration with cross-functional teams and development of robust manufacturing processes.

The ideal candidate will have a Bachelor’s degree in Engineering and over 5 years of experience in manufacturing, preferably within regulated industries. Strong knowledge of process validation and CNC machining is required. Join Harba to drive engineering excellence and support new product launches.

Qualifications

• Bachelor's degree in relevant engineering field.
• 5+ years in manufacturing engineering, preferably in regulated industries.
• Knowledge of process validation and regulatory requirements.

Responsibilities

• Lead new product introduction (NPI) activities.
• Collaborate with teams to meet project deliverables.
• Develop and sustain manufacturing processes.

Skills

Process validation

Regulatory compliance (FDA, ISO 13485)

CNC machining processes

Project management

Problem-solving

Lean methodologies

Six Sigma

Education

Bachelor’s degree in Engineering

Tools

CNC equipment

Job description

Responsibilities

• Lead new product introduction (NPI) activities, ensuring smooth transfer of designs into full-scale manufacturing.
• Collaborate with cross-functional teams (quality, supply chain, scheduling, operations, design engineering) to meet project timelines and deliverables.
• Develop, implement, and sustain robust manufacturing processes to meet customer, site, and regulatory requirements.
• Drive process validation, equipment qualification, and documentation updates to ensure compliance with FDA, ISO 13485, and other relevant standards.
• Provide on-the-floor technical support, troubleshooting equipment and process issues to minimize downtime and maximize efficiency.
• Partner with suppliers and vendors to specify new equipment, materials, and tooling as needed.
• Lead or support capital improvement projects and continuous improvement initiatives to reduce cost, improve quality, and increase throughput.
• Act as a liaison between manufacturing and customers during product launch and ongoing support.
• Contribute to risk assessments, root cause investigations, and implementation of corrective/preventive actions (CAPA).
• Maintain accurate documentation in line with Good Manufacturing Practices (GMP) and company policies.
• Support CNC machining processes — including programming, process optimization, and troubleshooting — to ensure efficient, high-quality production of precision components.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, Industrial, or related field).
• 5+ years of experience in a manufacturing engineering role, preferably within medical device, pharmaceutical, or other regulated manufacturing environments.
• Strong knowledge of process validation, equipment qualification, and regulatory compliance (FDA, ISO 13485, GMP).
• Proven experience with new product introduction (NPI) and tech transfer from R&D to manufacturing.
• Hands‑on experience with CNC machining processes, equipment, and tooling.
• Familiarity with injection molding, assembly, or packaging processes in regulated industries is a plus.
• Experience troubleshooting production equipment and supporting daily operations.
• Knowledge of Lean, Six Sigma, or other continuous improvement methodologies.
• Strong project management, problem‑solving, and communication skills.
• Ability to collaborate with cross‑functional teams and manage multiple priorities simultaneously.