Manufacturing Engineer

Colonial Group; Fort Wayne, Northern (IN, KY); Hybrid; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

Colonial Group is seeking a Manufacturing Engineer to develop, implement, and maintain engineering methods and systems that meet site-specific, customer, and regulatory requirements. You will proactively communicate initiatives that support departmental, plant, and corporate goals.

As an engineering representative, you will support new product transfers through internal volume production, suppliers, and customer locations while collaborating with operations, quality, and purchasing teams to

Qualifikationen

• Bachelor’s degree in engineering with 2 years of manufacturing experience.
• Experience in ISO 13485, ISO 9001, or medical device manufacturing environment preferred.
• Strong problem solving and root cause analysis tools proficiency.
• Ability to effectively work and communicate within a team and cross functionally.
• Solid understanding of Lean or TOC improvement initiatives.
• Excellent customer service skills via written and verbal communication.
• Modeling/drafting experience with SolidWorks or similar CAD systems.
• Familiarity with drafting standards and GD&T.
• Familiarity with CAM systems such as Mastercam, Esprit, Partmaker is a plus.

Aufgaben

• Apply advanced troubleshooting and root cause analysis methods to solve problems with documented results.
• Directly supports the operations team.
• Directly supports the qualification and validation activities associated with manufacturing equipment and special processes.
• Design and implement robust production processes and methods assuring that process capabilities are adequate to support business needs.
• Develop work instructions and necessary documentation to train associates and sustain manufacturing proficiencies.
• Collaborate with cross-functional teams to develop and coordinate new product introductions and sustain existing products.
• Act as the primary liaison between customers and internal teams for both new and legacy projects, ensuring alignment on goals and expectations.
• Develop project quotes, including cost estimation, pricing margins, and alignment with corporate financial goals.
• Lead new product projects as project manager, ensuring quality, on-time delivery, and compliance with ISO, FDA, and customer specifications.
• Create and manage Device Master Records (DMR), manufacturing processes, and design-for-manufacturing initiatives to optimize cost, quality, and delivery.
• Oversee post‑production activities and manage Non‑Conformance Material Reports (NCMR) to ensure product quality and compliance.
• Drive continuous improvement initiatives and provide support to quality, operations, and purchasing teams to meet corporate goals.

Kenntnisse

Root cause analysis

Problem solving

Cross-functional teamwork

Lean manufacturing

TOC improvement

Communication

Ausbildung

Bachelor's degree in engineering

Tools

SolidWorks

Mastercam

Esprit

Partmaker

Jobbeschreibung

We are seeking a Manufacturing Engineer to join our team. In this role, you will develop, implement, and maintain engineering methods and systems to meet site‑specific, customer, and regulatory requirements. You will proactively communicate initiatives that support departmental, plant, and corporate operational goals. As an engineering representative, you will provide support and guidance for new product transfers through internal volume production, suppliers, and customer locations.

What You’ll Do:

• Apply advanced troubleshooting and root cause analysis methods to solve problems with documented results.
• Directly supports the operations team.
• Directly supports the qualification and validation activities associated with manufacturing equipment and special processes.
• Design and implement robust production processes and methods assuring that process capabilities are adequate to support business needs.
• Develop work instructions and necessary documentation to train associates and sustain manufacturing proficiencies.
• Collaborate with cross-functional teams (customer service, manufacturing, quality, scheduling, purchasing) to develop and coordinate new product introductions and sustain existing products.
• Act as the primary liaison between customers and internal teams for both new and legacy projects, ensuring alignment on goals and expectations.
• Develop project quotes, including cost estimation, pricing margins, and alignment with corporate financial goals.
• Lead new product projects as project manager, ensuring quality, on-time delivery, and compliance with ISO, FDA, and customer specifications.
• Create and manage Device Master Records (DMR), manufacturing processes, and design-for-manufacturing initiatives to optimize cost, quality, and delivery.
• Oversee post‑production activities and manage Non‑Conformance Material Reports (NCMR) to ensure product quality and compliance.
• Drive continuous improvement initiatives and provide support to quality, operations, and purchasing teams to meet corporate goals.

What You’ll Need:

• Bachelor’s degree in an engineering discipline with 2 years of manufacturing experience, or equivalent combination of education and experience.
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred.
• Strong background demonstrating proficiency with problem solving and root cause analysis tools.
• Must have the ability to effectively work and communicate within a team and cross functionally to expedite completion of critical project tasks.
• Solid understanding and ability to lead Lean or TOC improvement initiatives.
• Excellent customer service skills via written and verbal communication required.
• Modeling/drafting experience with Solidworks or similar CAD systems.
• Working knowledge of drafting standards and geometric dimensioning and tolerancing.
• Familiarity with MasterCam, Esprit, Partmaker, or similar CAM systems is a plus.