NPI Manufacturing Engineer — Medical Devices

Avalign Technologies; Fort Wayne (IN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Competitive compensation

Medical, dental, vision benefits

Tuition reimbursement

401(k) with company match

Job summary

Avalign Technologies in Fort Wayne, IN, is seeking a Manufacturing Engineer, New Product Introduction (NPI). You will develop and maintain engineering methods to meet regulatory requirements, support new product transfers, and drive alignment with customer specifications and delivery expectations.

You will collaborate with cross-functional teams, lead new product projects as project manager, create device master records, and oversee post-production activities to ensure quality and on-time

Qualifications

• Bachelor’s degree in an engineering discipline is required.
• 2 years of manufacturing experience preferred.
• Experience with ISO 13485/9001 in medical devices preferred.

Responsibilities

• Applies advanced troubleshooting and root cause analysis methods to solve problems with documented results.
• Directly supports the operations team.
• Supports qualification and validation activities for manufacturing equipment and processes.
• Designs and implements robust production processes and methods.
• Develops work instructions and necessary documentation to train associates.
• Collaborates with cross-functional teams to develop and coordinate new product introductions.
• Acts as liaison between customers and internal teams for new and legacy projects.

Skills

Root cause analysis

Problem solving

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Tools

Solidworks

Mastercam

Esprit

Partmaker

Job description

Avalign Technologies in Fort Wayne, IN, is seeking a Manufacturing Engineer, New Product Introduction (NPI). You will develop and maintain engineering methods to meet regulatory requirements, support new product transfers, and drive alignment with customer specifications and delivery expectations.

You will collaborate with cross-functional teams, lead new product projects as project manager, create device master records, and oversee post-production activities to ensure quality and on-time