NPI & Injection Molding Lead Engineer

Vaupell; Michigan; On-site; USD 90,000 - 120,000; Full time

Job summary

Vaupell seeks a seasoned Program Manager to lead new product introductions for large-scale injection mold programs in Constantine, MI. You will coordinate planning, drive DOEs, and ensure alignment with regulatory requirements and customer contracts.

The role requires expertise in SIM for medical validations, tool design, and QA systems, with leadership across cross-functional teams to deliver on time and within ROI targets.

Qualifications

• Bachelor’s degree in engineering or related field, or equivalent experience.
• Five years in a Program Manager role.
• Knowledge of SIM for medical validations.
• Experience with tool design, fixtures, and mold manufacturing.
• Familiar with GAMP guidelines for automation validation.
• Experience with DOE, SPC, and quality systems (ISO 9001/13485).

Responsibilities

• Provide DFM technical support to customers.
• Lead creation and analysis of DOEs.
• Quote new and existing parts; prepare proposals.
• Develop cost-reduction ideas and ROI requests.
• Manage CAPAs and supplier/customer documentation.
• Ensure compliance with ISO 9001/13485 and 21 CFR Part 820.
• Lead project teams; document requirements and timelines.
• Coordinate schedules, risk assessments and communication plans.

Skills

Program management

SIM for medical validations

Design for Manufacturing

DOEs

Quality systems knowledge

Lean / cost reduction

Analytical thinking

Education

Bachelor’s degree in engineering

Tools

Solid modeling

PLC programming

Mold Flow analysis

Job description

Vaupell seeks a seasoned Program Manager to lead new product introductions for large-scale injection mold programs in Constantine, MI. You will coordinate planning, drive DOEs, and ensure alignment with regulatory requirements and customer contracts.

The role requires expertise in SIM for medical validations, tool design, and QA systems, with leadership across cross-functional teams to deliver on time and within ROI targets.