Medical Device Process Engineer – Injection Molding

Actalent, Inc.; Noblesville (IN); On-site; USD 66,000 - 73,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan – Pre-tax and R

Life Insurance (Voluntary Life & AD&D)

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

Time Off/Leave (PTO, Vacation or Sick)

Job summary

Actalent, Inc. is seeking a Process Engineer to support manufacturing equipment and plastics processes for medical components in a highly regulated environment.

The role emphasizes process validation, continuous improvement, scrap reduction, and capacity optimization to ensure compliant, high-quality production. You will lead cross-functional teams, develop molding and extrusion processes, and drive data-driven improvements using DOE and quality methods to deliver robust results in a controlled

Qualifications

• 3–5 years of relevant process engineering or closely related experience.
• Bachelor’s degree in plastic process engineering or a related engineering field.
• Education, training, and hands-on experience with plastics and plastic processing.
• Experience with equipment and processes used to manufacture, assemble, test, and package plastic components.
• Strong skills in process improvement and continuous improvement within manufacturing environments.
• Experience with plastic injection molding and related process engineering.
• Ability to support and lead cross-functional project teams and collaborate effectively with manufacturing, maintenance, and tooling personnel.

Responsibilities

• Support and lead project teams to increase productivity, reduce scrap, implement lean practices, improve system availability, enhance safety, and elevate product quality.
• Develop molding and extrusion processes using scientific molding methods for robust, repeatable production.
• Write, review, and execute PVP, IQ, OQ, and PQ protocols and summary reports per cGMPs and ISO standards.
• Conduct root cause investigations related to NCR and CAPA, report findings, propose corrective actions, and verify effectiveness.
• Maintain SOPs for equipment operation, part inspection, equipment changeover, and preventive maintenance.
• Prepare capital requests for new equipment including justification, vendor quotes, and specifications.
• Coordinate timelines for equipment and process changes to meet manufacturing needs.
• Diagnose system/process failures and implement effective fixes with Maintenance and Tool Room teams.
• Identify safety improvements aligning with OSHA standards and promote a safe environment.
• Collaborate with manufacturing to study and improve processes using DOE and data-driven analysis.

Skills

Process engineering

Lean manufacturing

DOE

cGMPs knowledge

Cross-functional collaboration

Injection molding

Continuous improvement

Education

Bachelor’s degree in plastic process engineering

Job description

Actalent, Inc. is seeking a Process Engineer to support manufacturing equipment and plastics processes for medical components in a highly regulated environment.

The role emphasizes process validation, continuous improvement, scrap reduction, and capacity optimization to ensure compliant, high-quality production. You will lead cross-functional teams, develop molding and extrusion processes, and drive data-driven improvements using DOE and quality methods to deliver robust results in a controlled